No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | B454VTP12010 | VTP-1201 | VTP-1201 | VersaWrap is an absorbable implant (device), designed to serve as an interface b VersaWrap is an absorbable implant (device), designed to serve as an interface between target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet to render the Sheet a gelatinous, tissue adherent layer (gel in situ). The aqueous citrate Solution is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch. | JXI,FTM | Cuff, Nerve,Mesh, Surgical | 2 | VersaWrap |
2 | B454VTP22011 | VTP2201 | VTP2201 | VersaWrap Tendon Protector (K160364) is indicated for the management and protect VersaWrap Tendon Protector (K160364) is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. It is an absorbable implant (device), designed to serve as an interface between the tendon and tendon sheath or the surrounding tissues, which provides a non-constricting, protective encasement for injured tendons. VersaWrap is a thin membrane of alginate and glycosaminoglycan and is easy to handle, conformable, and is designed for easy placement under, around, or over the injured tendon. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. | OWW,FTM | Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon,Mesh, Surgical | 2 | VersaWrap Tendon Protector |
3 | B454VTP12011 | VTP1201 | VTP1201 | VersaWrap Tendon Protector (K200311) is indicated for the management and protect VersaWrap Tendon Protector (K200311) is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. It is an absorbable implant (device), designed to serve as an interface between the tendon and tendon sheath or the surrounding tissues, which provides a non-constricting, protective encasement for injured tendons. VersaWrap is a thin membrane of alginate and glycosaminoglycan and is easy to handle, conformable, and is designed for easy placement under, around, or over the injured tendon. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. | FTM | Mesh, Surgical | 2 | VersaWrap Tendon Protector |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10884523000573 | CRCRP303 | Collagen Repair Patch | Permacol | SOFRADIM PRODUCTION | |
2 | 10884523000566 | CRCRP505 | Collagen Repair Patch | Permacol | SOFRADIM PRODUCTION | |
3 | 10884523000269 | CRCRP510 | CRCRP510 | Collagen Repair Patch | Permacol | COVIDIEN LP |
4 | 10884523000245 | P152840 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
5 | 10884523000238 | P152830 | P152830 | Surgical Implant | Permacol | SOFRADIM PRODUCTION |
6 | 10884523000221 | P152050 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
7 | 10884523000214 | P152040 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
8 | 10884523000207 | P152030 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
9 | 10884523000191 | P151828 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
10 | 10884523000184 | P151520 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
11 | 10884523000177 | P151020 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
12 | 10884523000160 | P151015 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
13 | 10884523000153 | P151010 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
14 | 10884523000146 | P150510 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
15 | 10884523000139 | P101828 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
16 | 10884523000122 | P101520 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
17 | 10884523000115 | P101015 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
18 | 10884523000108 | P101010 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
19 | 10884523000092 | P100510 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
20 | 10884523000085 | P100308 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
21 | 10884523000078 | P100205 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
22 | 10884523000061 | P100204 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
23 | 10884523000054 | P100104 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
24 | 10884523000047 | P100055 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
25 | 10884523000030 | P050308 | P050308 | Surgical Implant | Permacol | COVIDIEN LP |
26 | 10884523000023 | P050205 | Surgical Implant | Permacol | SOFRADIM PRODUCTION | |
27 | 10884523000016 | P050104 | P050104 | Surgical Implant | Permacol | SOFRADIM PRODUCTION |
28 | 10884521196070 | 89222 | 89222 | Collagen Implant | Enduragen | SOFRADIM PRODUCTION |
29 | 10884521196063 | 89220 | 89220 | Collagen Implant | Enduragen | SOFRADIM PRODUCTION |
30 | 10884521190719 | 89225 | 89225 | Collagen Implant | Enduragen | SOFRADIM PRODUCTION |
31 | 10884521190702 | 89224 | 89224 | Collagen Implant | Enduragen | SOFRADIM PRODUCTION |
32 | 10884521190696 | 89223 | Collagen Implant | Enduragen | SOFRADIM PRODUCTION | |
33 | 10884521190689 | 89221 | 89221 | Collagen Implant | Enduragen | SOFRADIM PRODUCTION |
34 | 10856072005132 | F10068-0408 | F10068-0408 | TELAMax is a sterile bioscaffold composed of ovine (sheep) derived extracellular TELAMax is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene. TELAMax will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. TELAMax is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements. | TELAMax | TELA BIO, INC. |
35 | 10856072005088 | F10069-1822 | F10069-1822 | TELAMax 1S is a sterile bioscaffold composed of ovine (sheep) derived extracellu TELAMax 1S is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene. The device consists of two sides: a textured and smooth side. The textured side of the device, indicated with blue polypropylene, provides a surface conducive for tissue ingrowth. The smooth side of the device, containing clear polypropylene, provides a surface designed to minimize tissue attachment. TELAMax 1S will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. TELAMax 1S is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements. | TELAMax 1S | TELA BIO, INC. |
36 | 10856072005026 | F10068-1010 | F10068-1010 | TELAMax is a sterile bioscaffold composed of ovine (sheep) derived extracellular TELAMax is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene. TELAMax will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. TELAMax is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements. | TELAMax | TELA BIO, INC. |
37 | 10827002583310 | G58331 | C-SLH-4S-7X20-11 | Fortify TRG Tissue Repair Graft | Fortify | COOK BIOTECH INCORPORATED |
38 | 10827002583303 | G58330 | C-SLH-4S-7X10-11 | Fortify TRG Tissue Repair Graft | Fortify | COOK BIOTECH INCORPORATED |
39 | 10827002583297 | G58329 | C-SLH-4S-4X7-11 | Fortify TRG Tissue Repair Graft | Fortify | COOK BIOTECH INCORPORATED |
40 | 10827002583280 | G58328 | C-SLH-4S-2X3-11 | Fortify TRG Tissue Repair Graft | Fortify | COOK BIOTECH INCORPORATED |
41 | 10827002583273 | G58327 | C-SLH-4S-1X10-11 | Fortify TRG Tissue Repair Graft | Fortify | COOK BIOTECH INCORPORATED |
42 | 10827002528694 | G52869 | C-SLH-6H-5X30 | Biodesign Plastic Surgery Matrix | Biodesign | COOK BIOTECH INCORPORATED |
43 | 10827002528687 | G52868 | C-SLH-6H-2X30 | Biodesign Plastic Surgery Matrix | Biodesign | COOK BIOTECH INCORPORATED |
44 | 10827002314525 | G31452 | C-IHM-8X15-P | Biodesign Inguinal Hernia Graft | Biodesign | COOK BIOTECH INCORPORATED |
45 | 10827002314518 | G31451 | C-IHM-6X13-P | Biodesign Inguinal Hernia Graft | Biodesign | COOK BIOTECH INCORPORATED |
46 | 10827002311418 | G31141 | C-IHM-10X15 | Biodesign Inguinal Hernia Graft | Biodesign | COOK BIOTECH INCORPORATED |
47 | 10827002138084 | G13808 | SLH-4S-2X3 | Biodesign 4-Layer Tissue Graft | Biodesign | COOK BIOTECH INCORPORATED |
48 | 10827002138077 | G13807 | SLH-4S-3.5X5 | Biodesign 4-Layer Tissue Graft | Biodesign | COOK BIOTECH INCORPORATED |
49 | 10827002138060 | G13806 | SLH-4S-7X10 | Biodesign 4-Layer Tissue Graft | Biodesign | COOK BIOTECH INCORPORATED |
50 | 10827002131160 | G13116 | SLH-4S-4X7 | Biodesign 4-Layer Tissue Graft | Biodesign | COOK BIOTECH INCORPORATED |