Identity
- Trade Name
- BURNSHIELD FDA UDI
- Generic Name
- Burn gel FDA UDI
- Device Name
- BURNSHIELD ESSENTIAL BURN KIT LARGE FDA UDI
- Model / Reference
- 900820 FDA UDI
- Description
- BURNSHIELD ESSENTIAL BURN KIT LARGE FDA UDI
Identifiers
- Catalog Number
- 900820 FDA UDI
- Primary DI / UDI-DI
- 06007645005807 FDA UDI
- 510(k) Number
- K943728 FDA UDI
- FDA Product Code
- MGQ FDA UDI
- GMDN Term
- Burn gel FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Burn gelSynthetic polymer burn dressing, gel-coated
Burnshield by Burnshield (pty) Ltd — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic polymer burn dressing, gel-coated.
- BurnFree — WATER-JEL TECHNOLOGIES, L.L.C. · Class I
- First Responder — WATER-JEL TECHNOLOGIES, L.L.C. · Class I
- First Responder — WATER-JEL TECHNOLOGIES, L.L.C. · Class I
- Dukal — Dukal LLC · Class I
- XeroBurn Sterile Burn Dressing Blanket 60"x 70" — Dynarex Corp. · Class I
- BurnFree — WATER-JEL TECHNOLOGIES, L.L.C. · Class I
- First Responder — WATER-JEL TECHNOLOGIES, L.L.C. · Class I
- BurnFree — WATER-JEL TECHNOLOGIES, L.L.C. · Class I
Cleared under the same submission
K943728 also covers:
- ARAMARK — BURNSHIELD (PTY) LTD
- BURNSHIELD — BURNSHIELD (PTY) LTD
- BURNSHIELD — BURNSHIELD (PTY) LTD
- BURNSHIELD — BURNSHIELD (PTY) LTD
- BURNSHIELD — BURNSHIELD (PTY) LTD
- Burnshield — BURNSHIELD (PTY) LTD
- Burnshield — BURNSHIELD (PTY) LTD
- Burnshield — BURNSHIELD (PTY) LTD
- Burnshield — BURNSHIELD (PTY) LTD
- Burnshield — BURNSHIELD (PTY) LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Burnshield (pty) Ltd
Sources (1)
- FDA UDI 143e6e4c-cc3a-4049-9573-49b11dbf25dc 37 fields · synced May 30, 2026