Burnshield 881009
Burnshield 881009 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 06007645007672), 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 | Number06007645007672 | Date17 Dec 2018 | StatusListed |
| United States | FDA 510(k)SN | NumberK943728 | Date27 Sep 1994 | StatusActive |
Official records
- AccessGUDID record 06007645007672
- FDA 510(k) database K943728
Across registries
- FDA 510(k) K943728 decided 27 Sep 1994 Active
- FDA GUDID UDI-DI 06007645007672 listed 17 Dec 2018 Listed
Timeline
- Cleared FDA 510(k) K943728
- Listed FDA GUDID 06007645007672
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Burnshield
- Generic name
- Burn gel
- Model / Ref / Catalog
- 881009
- Primary DI / UDI-DI
- 06007645007672
- FDA product code
- MGQ
- GMDN term
- Burn gel
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic).
- CURASOL GEL WOUND DRESSING by DPT LABORATORIES, LTD.
- DERMAMEND GEL by Dermarx Corp.
- BIONECT HYDROGEL SPRAY by Fidia Pharmaceutical Corp.
- HYDRODERM GEL WOUND DRESSING by Wilshire Medical Products
- BRENNEN MEDICAL GLUCAN II WOUND DRESSING by Brennen Medical, LLC
- DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING by Wilshire Medical Products
- SWEEN WOUN'DRES by Coloplast Corp.
- CARRASYN HYDROGEL WOUND DRESSING, CARRAGAUZE PADS, CARRAGAUZE STRIPS, CARRASORB M FDG by Carrington Laboratories, Inc.
- X-CELL WOUND DRESSING by Xylos Corporation
- MPM HYDROGEL DRESSING (NON-STERILE) by MPM MEDICAL