Identity
- Trade Name
- BurnFree FDA UDI
- Generic Name
- Synthetic polymer burn dressing, gel-coated FDA UDI
- Device Name
- BurnFree 10cm x 10cm (4"X4") Burn Dressing 60/cs; BD Gel FDA UDI
- Model / Reference
- 101060.00.000 FDA UDI
- Description
- BurnFree 10cm x 10cm (4"X4") Burn Dressing 60/cs; BD Gel FDA UDI
Identifiers
- Catalog Number
- 101060.00.000 FDA UDI
- Primary DI / UDI-DI
- 00743537000258 FDA UDI
- FDA Product Code
- NAE FDA UDI
- GMDN Term
- Synthetic polymer burn dressing, gel-coated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4022 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Synthetic polymer burn dressing, gel-coated
BurnFree by Water-Jel Technologies, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic polymer burn dressing, gel-coated.
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- Dukal — Dukal LLC · Class I
- XeroBurn Sterile Burn Dressing Blanket 60"x 70" — Dynarex Corp. · Class I
- BURNSHIELD — BURNSHIELD (PTY) LTD · U
- XeroBurn Sterile Burn Dressing — Dynarex Corp. · Class I
- Rhino Rescue — EMSRUN GROUP · Class I
- DynaSafety XeroBurn Sterile Burn Dressing, 8" x 8" — Dynarex Corp. · Class I
- Redicare — REDICARE LLC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Water-Jel Technologies, L.l.c.
Sources (1)
- FDA UDI 443c8f56-af09-4d23-a4ac-7f1fe5042a47 35 fields · synced May 30, 2026