Burnshield 881060
Burnshield 881060 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 25 Jul 2020 (UDI-DI 06007645007641), 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 | Number06007645007641 | Date25 Jul 2020 | StatusListed |
| United States | FDA 510(k)SN | NumberK943728 | Date27 Sep 1994 | StatusActive |
Official records
- AccessGUDID record 06007645007641
- FDA 510(k) database K943728
Across registries
- FDA 510(k) K943728 decided 27 Sep 1994 Active
- FDA GUDID UDI-DI 06007645007641 listed 25 Jul 2020 Listed
Timeline
- Cleared FDA 510(k) K943728
- Listed FDA GUDID 06007645007641
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Burnshield
- Generic name
- Cotton burn dressing, non-antimicrobial
- Model / Ref / Catalog
- 881060
- Primary DI / UDI-DI
- 06007645007641
- FDA product code
- MGQ
- GMDN term
- Cotton burn dressing, non-antimicrobial
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 1000 MillimeterWidth — 1000 MillimeterWeight — 900 Gram
Similar devices
Other devices filed under FDA product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic).
- SILVERSITE OR CALGITROL by Adri
- L.A.M. IPM WOUND GEL by L.A.M. Pharmaceutical, Corp.
- DUODERM HYDROACTIVE DRESSING AND CGF DRESSINGS by Convatec, A Division of E.R. Squibb & Sons
- POLYTUBE by Ferris Mfg. Corp.
- CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING by Cardiotech Intl.
- HYDRO-M(TM) WOUND GEL by Kingston Technologies, Inc.
- ROYL-DERM WOUND HYDROGEL STERILE UNIT DOSE by Renaissance Medical, Inc.
- WOUND HYDROGEL & STERILE WOUND HYDROGEL by Renaissance Pharmaceutical, Inc.
- BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET by Emox 911 CC
- SPYROGEL HYDROGEL WOUND AND BURN DRESSING by Innovative Technologies (Us), Inc.