TransCyte 10633
TransCyte 10633 is a Class III device made by Organogenesis Inc., listed under FDA premarket submission BP960700 and listed in FDA GUDID since 12 Jan 2018 (UDI-DI 00618474000046), active as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
PMA BP960700
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00618474000046 | Date12 Jan 2018 | StatusListed |
| United States | FDA PMA | NumberBP960700 | Date— | StatusActive |
Official records
- AccessGUDID record 00618474000046
Across registries
- FDA premarket submission BP960700 Active
- FDA GUDID UDI-DI 00618474000046 listed 12 Jan 2018 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- TransCyte
- Generic name
- Skin regeneration template, human-/animal-derived
- Model / reference
- 10633
- Primary DI / UDI-DI
- 00618474000046
- FDA product code
- MGR
- GMDN term
- Skin regeneration template, human-/animal-derived
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution