No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | M2138069M0K15 | 8069M0K1 | Radiesse Injectable Implant is a volumizing filler indicated for subdermal impla Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles. | LMH | Implant, Dermal, For Aesthetic Use | 3 | Radiesse Moderate Fill 0.8cc | |
2 | M2138071M0K15 | 8071M0K1 | Radiesse Injectable Implant is a volumizing filler indicated for subdermal impla Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles. | LMH | Implant, Dermal, For Aesthetic Use | 3 | Radiesse Volume Advantage 1.5cc | |
3 | M2138071C0K15 | 8071C0K1 | Radiesse Injectable Implant is a volumizing filler indicated for subdermal impla Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles. RADIESSE injectable implant is also indicated for hand augmentation to correct volume loss in the dorsum of the hands. | PKY,LMH | Implant, Dermal, For Aesthetic Use In The Hands,Implant, Dermal, For Aesthetic Use | 3 | Radiesse Volume Advantage 1.5cc | |
4 | M2138063M0K25 | 8063M0K2 | Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with inte Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (2) 1.5cc Injectable Implant and (4) 27 gauge thin walled x 0.75" needles. | LMH | Implant, Dermal, For Aesthetic Use | Radiesse (+) Lidocaine | ||
5 | M2138700M05 | 8700M0 | Belotero Balance is a hyaluronic-acid based dermal filler approved for injection Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. Belotero Balance kit contains (1) injectable implant and 2 needles - 30 Gauge x 1/2 inch, and 27 Gauge x 1/2 inch. | LMH | Implant, Dermal, For Aesthetic Use | 3 | Belotero Balance | |
6 | M2138044M0K55 | 8044M0K5 | Prolaryn Plus is a water based injectable gel implant used to treat vocal fold i Prolaryn Plus is a water based injectable gel implant used to treat vocal fold insufficiency. The principle component of Prolaryn Plus is synthetic calcium hydroxyapatite, a biomaterial found in bone and teeth. Injection with Prolaryn Plus augments or bulks ups the displaced or damaged vocal fold so that it can improve speaking. The result is long term restoration and augmentation. Prolaryn Plus can be injected with a 26 gauge or larger diameter thin-wall-needle. | MIX | System, Vocal Cord Medialization | 2 | Prolaryn Plus Injectable Implant | |
7 | M2138071M0K25 | 8071M0K2 | Radiesse Injectable Implant is a volumizing filler indicated for subdermal impla Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (2) injectable implants and (4) 27 gauge thin walled x 0.75 inch needles. | LMH | Implant, Dermal, For Aesthetic Use | Radiesse Volume Advantage | ||
8 | M2138071M0H15 | 8071M0H1 | Radiesse Injectable Implant is a volumizing filler intended for restoration and/ Radiesse Injectable Implant is a volumizing filler intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles. | LMH | Implant, Dermal, For Aesthetic Use | 3 | Radiesse Injectable Implant1.5cc | |
9 | M2138067M0K15 | 8067M0K1 | Radiesse (+) Lidocaine Injectable Implant is a volumizing filler with lidocaine Radiesse (+) Lidocaine Injectable Implant is a volumizing filler with lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 0.8cc Injectable Implant and (2) 27 gauge thin walled x 0.75" needles. | LMH | Implant, Dermal, For Aesthetic Use | 3 | Radiesse (+) Lidocaine 0.8cc Injectable Implant | |
10 | M2138063M0K15 | 8063M0K1 | Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with inte Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 1.5cc Injectable Implant and (2) 27 gauge thin walled x 0.75" needles. | LMH | Implant, Dermal, For Aesthetic Use | 3 | Radiesse (+) Lidocaine1.5cc Injectable Implant | |
11 | 00186295000366 | 5035836 | Individually packaged DeScribe PFD Patch (each). Contains 2 Describe PFD Patches. | PKO | Transparent Patch For Use In Treatment Of Tattoos | 2 | DeScribe Transparent PFD Patch | |
12 | 00186295000359 | 5035837 | Individually packaged DeScribe PFD Patch (each) | PKO | Transparent Patch For Use In Treatment Of Tattoos | DeScribe Transparent PFD Patch | ||
13 | 00186295000342 | 5035838 | Individually packaged DeScribe PFD Patch (each)Contains 5 DeScribe PFD Patches. | PKO | Transparent Patch For Use In Treatment Of Tattoos | 2 | DeScribe Transparent PFD Patch | |
14 | 08714729804796 | 8005P10 | M0068903000 | The Coaptite Injectable Implant is a permanently implanted device used to treat The Coaptite Injectable Implant is a permanently implanted device used to treat women who have severe stress urinary incontinence due to poorly functioning urethral sphincter muscles. | LNM | Agent, Bulking, Injectable For Gastro-Urology Use | 3 | Coaptite |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B611SV30012 | SV3001 | SV3001 | SilkVoice injectable implant and accessory kit. | SilkVoice | SOFREGEN MEDICAL INC. |
2 | B611SV3001 | SV3001 | SV3001 | SilkVoice injectable implant and accessory kit. | SilkVoice | SOFREGEN MEDICAL INC. |
3 | B611SV20011 | SV2001 | SV2001 | SilkVoice catheter 70cm | SilkVoice | SOFREGEN MEDICAL INC. |
4 | B611SV2001 | SV2001 | SV2001 | SilkVoice catheter 70cm | SilkVoice | SOFREGEN MEDICAL INC. |
5 | B611SV10021 | SV1002 | SV1002 | SilkVoice Injectable Implant, 1cc Syringe, 2 each | SilkVoice | SOFREGEN MEDICAL INC. |
6 | B611SV1002 | SV1002 | SV1002 | SilkVoice Injectable Implant, 1cc Syringe, 2 each | SilkVoice | SOFREGEN MEDICAL INC. |
7 | B611SV10011 | SV1001 | SV1001 | SilkVoice Injectable Implant, 1cc Syringe, 2 needles | SilkVoice | SOFREGEN MEDICAL INC. |
8 | B611SV1001 | SV1001 | SV1001 | SilkVoice Injectable Implant, 1cc Syringe, 2 needles | SilkVoice | SOFREGEN MEDICAL INC. |
9 | 14063107102841 | MT-225 | MT-225 | Tray Only | Montgomery® Thyroplasty Instrument Tray | BOSTON MEDICAL PRODUCTS, INC. |
10 | 14063107102766 | MT-200P | MT-200P | Contains one each of MT-201, MT-202, MT-203, MT-204, MT-205, MT-206, MT-207, MT- Contains one each of MT-201, MT-202, MT-203, MT-204, MT-205, MT-206, MT-207, MT-208, MT-209, MT-210, MT-211, MT-212, & MT-213. | Montgomery® Thyroplasty Instrument Set | BOSTON MEDICAL PRODUCTS, INC. |
11 | 14063107102636 | MT-400 | MT-400 | Type: Male | Montgomery® Thyroplasty Measuring Kit | BOSTON MEDICAL PRODUCTS, INC. |
12 | 14063107102629 | MT-300 | MT-300 | Type: Female | Montgomery® Thyroplasty Measuring Kit | BOSTON MEDICAL PRODUCTS, INC. |
13 | 14063107102612 | MT-213 | MT-213 | Male Implant Inserter | Montgomery® Thyroplasty Instrument | BOSTON MEDICAL PRODUCTS, INC. |
14 | 14063107102605 | MT-212 | MT-212 | Female Implant Inserter | Montgomery® Thyroplasty Instrument | BOSTON MEDICAL PRODUCTS, INC. |
15 | 14063107102599 | MT-211 | MT-211 | Chisel Elevator | Montgomery® Thyroplasty Instrument | BOSTON MEDICAL PRODUCTS, INC. |
16 | 14063107102582 | MT-210 | MT-210 | 5 mm Duckbill Elevator | Montgomery® Thyroplasty Instrument | BOSTON MEDICAL PRODUCTS, INC. |
17 | 14063107102575 | MT-209 | MT-209 | 3 mm Duckbill Elevator | Montgomery® Thyroplasty Instrument | BOSTON MEDICAL PRODUCTS, INC. |
18 | 14063107102568 | MT-208 | MT-208 | Large Sharp Hook | Montgomery® Thyroplasty Instrument | BOSTON MEDICAL PRODUCTS, INC. |
19 | 14063107102551 | MT-207 | MT-207 | Small Sharp Hook | Montgomery® Thyroplasty Instrument | BOSTON MEDICAL PRODUCTS, INC. |
20 | 14063107102544 | MT-206 | MT-206 | Large Curved Hook | Montgomery® Thyroplasty Instrument | BOSTON MEDICAL PRODUCTS, INC. |
21 | 14063107102537 | MT-205 | MT-205 | Small Curved Hook | Montgomery® Thyroplasty Instrument | BOSTON MEDICAL PRODUCTS, INC. |
22 | 14063107102520 | MT-204 | MT-204 | Male Outline Instrument | Montgomery® Thyroplasty Instrument | BOSTON MEDICAL PRODUCTS, INC. |
23 | 14063107102513 | MT-203 | MT-203 | Female Outline Instrument | Montgomery® Thyroplasty Instrument | BOSTON MEDICAL PRODUCTS, INC. |
24 | 14063107102506 | MT-202 | MT-202 | 9 mm Male Window Caliper | Montgomery® Thyroplasty Instrument | BOSTON MEDICAL PRODUCTS, INC. |
25 | 14063107102490 | MT-201 | MT-201 | 7 mm Female Window Caliper | Montgomery® Thyroplasty Instrument | BOSTON MEDICAL PRODUCTS, INC. |
26 | 14063107102483 | MT-200 | MT-200 | Contains one each of MT-201, MT-202, MT-203, MT-204, MT-205, MT-206, MT-207, MT- Contains one each of MT-201, MT-202, MT-203, MT-204, MT-205, MT-206, MT-207, MT-208, MT-209, MT-210, MT-211, MT-212, & MT-213. | Montgomery® Thyroplasty Instrument Set | BOSTON MEDICAL PRODUCTS, INC. |
27 | 14063107101868 | MTM-13 | MTM-13 | Size: Male 13 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
28 | 14063107101851 | MTM-12 | MTM-12 | Size: Male 12 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
29 | 14063107101844 | MTM-11 | MTM-11 | Size: Male 11 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
30 | 14063107101837 | MTM-10 | MTM-10 | Size: Male 10 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
31 | 14063107101820 | MTM-09 | MTM-09 | Size: Male 9 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
32 | 14063107101813 | MTM-08 | MTM-08 | Size: Male 8 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
33 | 14063107101806 | MTF-11 | MTF-11 | Size: Female 11 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
34 | 14063107101790 | MTF-10 | MTF-10 | Size: Female 10 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
35 | 14063107101783 | MTF-09 | MTF-09 | Size: Female 9 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
36 | 14063107101776 | MTF-08 | MTF-08 | Size: Female 8 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
37 | 14063107101769 | MTF-07 | MTF-07 | Size: Female 7 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
38 | 14063107101752 | MTF-06 | MTF-06 | Size: Female 6 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
39 | M2138602M0K55 | 8602M0K5 | Prolaryn Gel is a water-based injectable gel implant used in the vocal folds to Prolaryn Gel is a water-based injectable gel implant used in the vocal folds to treat vocal fold insuffiency. Prolaryn Gel resorbs within a period of 3-6 months and is a temporary implant. | Prolaryn Gel Injectable Implant | MERZ NORTH AMERICA, INC. | |
40 | M2138044M0K55 | 8044M0K5 | Prolaryn Plus is a water based injectable gel implant used to treat vocal fold i Prolaryn Plus is a water based injectable gel implant used to treat vocal fold insufficiency. The principle component of Prolaryn Plus is synthetic calcium hydroxyapatite, a biomaterial found in bone and teeth. Injection with Prolaryn Plus augments or bulks ups the displaced or damaged vocal fold so that it can improve speaking. The result is long term restoration and augmentation. Prolaryn Plus can be injected with a 26 gauge or larger diameter thin-wall-needle. | Prolaryn Plus Injectable Implant | MERZ NORTH AMERICA, INC. | |
41 | 05060457760082 | 8071M5K1 | Radiesse | LAMBSMEAD LTD | ||
42 | EBESMTM130 | MTM-13 | MTM-13 | Size: Male 13 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
43 | EBESMTM120 | MTM-12 | MTM-12 | Size: Male 12 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
44 | EBESMTM110 | MTM-11 | MTM-11 | Size: Male 11 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
45 | EBESMTM100 | MTM-10 | MTM-10 | Size: Male 10 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
46 | EBESMTM090 | MTM-09 | MTM-09 | Size: Male 9 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
47 | EBESMTM080 | MTM-08 | MTM-08 | Size: Male 8 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
48 | EBESMTM011 | MTM-01 | MTM-01 | Type: Male.Contains two each of MTM-08 & MTM-09.Contains four each of MTM-10, MT Type: Male.Contains two each of MTM-08 & MTM-09.Contains four each of MTM-10, MTM-11, & MTM-12. | Montgomery® Thyroplasty Implant Set | BOSTON MEDICAL PRODUCTS, INC. |
49 | EBESMTF110 | MTF-11 | MTF-11 | Size: Female 11 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |
50 | EBESMTF100 | MTF-10 | MTF-10 | Size: Female 10 | Montgomery® Thyroplasty Implant | BOSTON MEDICAL PRODUCTS, INC. |