Burnshield 881008
Burnshield 881008 is a device classified as Unclassified made by Burnshield (Pty) Ltd, cleared under FDA 510(k) K943728 on 27 Sep 1994 and listed in FDA GUDID since 17 Dec 2018 (UDI-DI 06007645007665), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06007645007665 | Date17 Dec 2018 | StatusListed |
| United States | FDA 510(k)SN | NumberK943728 | Date27 Sep 1994 | StatusActive |
Official records
- AccessGUDID record 06007645007665
- FDA 510(k) database K943728
Across registries
- FDA 510(k) K943728 decided 27 Sep 1994 Active
- FDA GUDID UDI-DI 06007645007665 listed 17 Dec 2018 Listed
Timeline
- Cleared FDA 510(k) K943728
- Listed FDA GUDID 06007645007665
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Burnshield
- Generic name
- Burn gel
- Model / Ref / Catalog
- 881008
- Primary DI / UDI-DI
- 06007645007665
- FDA product code
- MGQ
- GMDN term
- Burn gel
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
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