Cellusheet, Cellufil
Human Biosciences, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008770963 | 3008770963 | HUMAN BIOSCIENCES, INC. | 1 | N | 2026-01-01 | 600 N Queen St Martinsburg WV US 25404 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850048866034 | Celluheal - Cellusheet sterile collagen wound dressing, 2x2 sheet | 301-740-1893 | info@humanbiosciences.com |
| 00850048866058 | Medifil - Medifil sterile collagen particles, 1 gram pouch | 301-740-1893 | info@humanbiosciences.com |
| 00850048866089 | SkinTemp II - SkinTemp sterile collagen wound dressing, 3x4 sheet | 301-740-1893 | info@humanbiosciences.com |
| 00850048866096 | SkinTemp II - SkinTemp sterile collagen wound dressing, 2x2 sheet | 301-740-1893 | info@humanbiosciences.com |
| 00850048866102 | SkinTemp II - SkinTemp sterile collagen wound dressing, 7x7 sheet | 301-740-1893 | info@humanbiosciences.com |
| 00850048866928 | Celluheal - Cellufil sterile collagen particles, 1 pouch | 3017401893 | info@humanbiosciences.com |
| 00850048866966 | Collecule LpH - Collecule LpH Surgical Collagen powder, 1gram | 3017401893 | info@humanbiosciences.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 123051 | 1276538324 | K913023 | SKINTEMP | KGN | 1991-10-02 |
| 123051 | 1846709173 | K910944 | MEDIFIL | KGN | 1991-04-02 |
| 123051 | 1487778654 | K213092 | Cellusheet, Cellufil | KGN | 2021-12-15 |
| 123051 | 1939408414 | K122325 | SKINTEMP II | KGN | 2012-10-26 |
| 123051 | 1116056830 | K022995 | COLLATEK HYDROGEL | MGQ | 2002-12-02 |
| 123051 | 1434719112 | K012990 | COLLATEK POWDER | KGN | 2001-10-24 |
| 123051 | 1370146420 | ||||
| 123051 | 1495248375 | ||||
| 123051 | 1763914802 |
Human Biosciences, Inc.
HUMAN BIOSCIENCES, INC.
2025-11-17
2025-11-17
2025-06-16
2023-09-28
2023-06-19
2023-06-19
2023-06-19
2023-06-19
2023-06-19
2023-06-19
2023-09-28
2023-06-19
2025-06-16
2023-09-28
2023-06-19
2023-06-19
2023-06-19
2023-06-19
2023-06-19
2023-06-19