Other products from "TEPHA, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00855920006089 100035-28 GP019M GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydr GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFLEX Scaffold
2 00855920006133 100035-17 GP0104 GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydr GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFLEX Scaffold
3 00855920006126 100035-25 GP017M GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydr GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFLEX Scaffold
4 00855920006119 100035-26 GP017S GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydr GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFLEX Scaffold
5 00855920006102 100035-19 GP013M GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydr GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFLEX Scaffold
6 00855920006096 100035-20 GP013S GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydr GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFLEX Scaffold
7 00855920006072 100035-29 GP019S GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydr GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFLEX Scaffold
8 00855920006065 100035-22 GP016M GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydr GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFLEX Scaffold
9 00855920006058 100035-23 GP016S GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydr GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFLEX Scaffold
10 00855920006041 100035-09 GP0608 GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydr GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFLEX Scaffold
11 00855920006034 100035-15 GP0408 GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydr GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFLEX Scaffold
12 00855920006027 100035-14 GP0208 GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydr GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFLEX Scaffold
13 00855920006010 100035-01 GP0206 GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydr GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFLEX Scaffold
14 00855920006003 100035-05 GP0103 GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydr GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFLEX Scaffold
15 00810054980575 100027-15 GFLT1020 GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from p GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFLEX LITE
16 00810054980551 100027-01 GFLT0515 GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from p GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFLEX LITE
17 00855920006799 100043-31 CEFR11 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFORM 3D
18 00855920006829 100043-34 CEFR14 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFORM 3D
19 00855920006812 100043-33 CEFR13 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFORM 3D
20 00855920006805 100043-32 CEFR12 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFORM 3D
21 00855920006782 100043-30 CEFR10 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFORM 3D
22 00855920006775 100043-29 CEFR09 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFORM 3D
23 00855920006768 100043-27 CEFR07 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFORM 3D
24 00855920006751 100043-26 CEFR06 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFORM 3D
25 00855920006744 100043-25 CEFR05 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFORM 3D
26 00855920006737 100043-24 CEFR04 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFORM 3D
27 00855920006720 100043-23 CEFR03 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFORM 3D
28 00855920006713 100043-22 CEFR02 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFORM 3D
29 00855920006706 100043-21 CEFR01 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFORM 3D
30 00855920006355 100043-14 FR3D14 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFORM 3D
31 00855920006348 100043-13 FR3D13 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFORM 3D
32 00855920006331 100043-12 FR3D12 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFORM 3D
33 00855920006324 100043-11 FR3D11 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFORM 3D
34 00855920006317 100043-10 FR3D10 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFORM 3D
35 00855920006300 100043-09 FR3D09 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFORM 3D
36 00855920006287 100043-07 FR3D07 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFORM 3D
37 00855920006270 100043-06 FR3D06 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFORM 3D
38 00855920006263 100043-05 FR3D05 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFORM 3D
39 00855920006256 100043-04 FR3D04 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFORM 3D
40 00855920006249 100043-03 FR3D03 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFORM 3D
41 00855920006232 100043-02 FR3D02 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFORM 3D
42 00855920006225 100043-01 FR3D01 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. OOD Surgical Film 2 GalaFORM 3D
43 00810054980568 100027-14 GFLT0520 GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from p GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFLEX LITE
44 00810054980636 100027-32 GFLT0019 GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from p GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFLEX LITE
45 00810054980629 100027-31 GFLT0017 GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from p GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFLEX LITE
46 00810054980612 100027-30 GFLT0015 GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from p GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFLEX LITE
47 00810054980605 100027-29 GFLT0013 GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from p GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFLEX LITE
48 00810054980599 100027-06 GFLT0008 GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from p GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFLEX LITE
49 00810054980582 100027-09 GFLT1520 GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from p GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFLEX LITE
50 00810054980544 100027-05 GFLT0207 GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from p GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. OOD Surgical Film 2 GalaFLEX LITE
Other products with the same Product Code "OOD"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00855920006270 100043-06 FR3D06 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. GalaFORM 3D TEPHA, INC.
2 00855920006263 100043-05 FR3D05 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. GalaFORM 3D TEPHA, INC.
3 00855920006256 100043-04 FR3D04 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. GalaFORM 3D TEPHA, INC.
4 00855920006249 100043-03 FR3D03 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. GalaFORM 3D TEPHA, INC.
5 00855920006232 100043-02 FR3D02 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. GalaFORM 3D TEPHA, INC.
6 00855920006225 100043-01 FR3D01 GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-h GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. GalaFORM 3D TEPHA, INC.
7 00855920006218 100042-08 SH3D08 GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4- GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a slight 3D curvature designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaSHAPE 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. GalaSHAPE 3D TEPHA, INC.
8 00855920006201 100042-07 SH3D07 GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4- GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a slight 3D curvature designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaSHAPE 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. GalaSHAPE 3D TEPHA, INC.
9 00855920006195 100042-06 SH3D06 GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4- GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a slight 3D curvature designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaSHAPE 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. GalaSHAPE 3D TEPHA, INC.
10 00855920006188 100042-05 SH3D05 GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4- GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a slight 3D curvature designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaSHAPE 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. GalaSHAPE 3D TEPHA, INC.
11 00855920006171 100042-04 SH3D04 GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4- GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a slight 3D curvature designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaSHAPE 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. GalaSHAPE 3D TEPHA, INC.
12 00855920006164 100042-03 SH3D03 GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4- GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a slight 3D curvature designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaSHAPE 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. GalaSHAPE 3D TEPHA, INC.
13 00855920006157 100042-02 SH3D02 GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4- GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a slight 3D curvature designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaSHAPE 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. GalaSHAPE 3D TEPHA, INC.
14 00855920006140 100042-01 SH3D01 GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4- GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a slight 3D curvature designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaSHAPE 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. GalaSHAPE 3D TEPHA, INC.
15 00855920006133 100035-17 GP0104 GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydr GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. GalaFLEX Scaffold TEPHA, INC.
16 00855920006126 100035-25 GP017M GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydr GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.Pre-clinical implantation studies indicate that GalaFLEX scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. GalaFLEX Scaffold TEPHA, INC.
17 00855920006829 100043-34 CEFR14 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFORM 3D TEPHA, INC.
18 00855920006812 100043-33 CEFR13 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFORM 3D TEPHA, INC.
19 00855920006805 100043-32 CEFR12 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFORM 3D TEPHA, INC.
20 00855920006799 100043-31 CEFR11 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFORM 3D TEPHA, INC.
21 00855920006782 100043-30 CEFR10 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFORM 3D TEPHA, INC.
22 00855920006775 100043-29 CEFR09 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFORM 3D TEPHA, INC.
23 00855920006768 100043-27 CEFR07 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFORM 3D TEPHA, INC.
24 00855920006751 100043-26 CEFR06 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFORM 3D TEPHA, INC.
25 00855920006744 100043-25 CEFR05 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFORM 3D TEPHA, INC.
26 00855920006737 100043-24 CEFR04 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFORM 3D TEPHA, INC.
27 00855920006720 100043-23 CEFR03 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFORM 3D TEPHA, INC.
28 00855920006713 100043-22 CEFR02 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFORM 3D TEPHA, INC.
29 00855920006706 100043-21 CEFR01 GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from pol GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFORM 3D TEPHA, INC.
30 00855920006690 100035-37 CE0104 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFLEX TEPHA, INC.
31 00855920006683 100035-45 CE017M GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFLEX TEPHA, INC.
32 00855920006676 100035-46 CE017S GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFLEX TEPHA, INC.
33 00855920006669 100035-39 CE013M GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFLEX TEPHA, INC.
34 00855920006652 100035-40 CE013S GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFLEX TEPHA, INC.
35 00855920006645 100035-48 CE019M GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFLEX TEPHA, INC.
36 00855920006638 100035-49 CE019S GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFLEX TEPHA, INC.
37 00855920006621 100035-42 CE016M GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFLEX TEPHA, INC.
38 00855920006614 100035-43 CE016S GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFLEX TEPHA, INC.
39 00855920006607 100035-34 CE0608 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFLEX TEPHA, INC.
40 00855920006591 100035-36 CE0408 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFLEX TEPHA, INC.
41 00855920006584 100035-35 CE0208 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFLEX TEPHA, INC.
42 00855920006577 100035-30 CE0206 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFLEX TEPHA, INC.
43 00855920006560 100035-33 CE0103 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaFLEX TEPHA, INC.
44 00855920006553 100042-34 CESH14 GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from po GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaSHAPE 3D TEPHA, INC.
45 00855920006546 100042-33 CESH13 GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from po GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaSHAPE 3D TEPHA, INC.
46 00855920006539 100042-32 CESH12 GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from po GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaSHAPE 3D TEPHA, INC.
47 00855920006522 100042-31 CESH11 GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from po GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaSHAPE 3D TEPHA, INC.
48 00855920006515 100042-30 CESH10 GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from po GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaSHAPE 3D TEPHA, INC.
49 00855920006508 100042-29 CESH09 GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from po GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaSHAPE 3D TEPHA, INC.
50 00855920006492 100042-28 CESH08 GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from po GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. GalaSHAPE 3D TEPHA, INC.