Identity
- Trade Name
- Mundial EUDAMEDBurnshield FDA UDI
- Generic Name
- Burn gel FDA UDI
- Device Name
- Mundial Home / Travel Burn Kit EUDAMEDMUNDIAL HOME/TRAVEL KIT FDA UDI
- Model / Reference
- L550008F EUDAMED550008F FDA UDI
- Description
- MUNDIAL HOME/TRAVEL KIT FDA UDI
Identifiers
- Catalog Number
- 550008F FDA UDI
- Primary DI / UDI-DI
- 06007645006354 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06007645006354 EUDAMED
- 510(k) Number
- K943728 FDA UDI
- FDA Product Code
- MGQ FDA UDI
- EMDN Code
- M0408 DRESSINGS FOR BURNS ONLY EUDAMED
- GMDN Term
- Burn gel FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDU FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Burnshield (pty) Ltd
Sources (2)
- FDA UDI ad93887b-41ef-4994-8cb8-3b26358413ef 37 fields · synced Jul 9, 2026
- EUDAMED 1c9070c2-a0fa-4518-993f-84b778abf3f2 61 fields · synced Jul 9, 2026