Identity
- Trade Name
- BurnFree FDA UDI
- Generic Name
- Burn gel FDA UDI
- Device Name
- BurnFree 20, 3.5g, 20pc/bx 30bx/cs; BD Gel FDA UDI
- Model / Reference
- SD20.00.000 FDA UDI
- Description
- BurnFree 20, 3.5g, 20pc/bx 30bx/cs; BD Gel FDA UDI
Identifiers
- Catalog Number
- SD20.00.000 FDA UDI
- Primary DI / UDI-DI
- 00743537000777 FDA UDI
- 510(k) Number
- K990180 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
No
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
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 gel
BurnFree by Water-Jel Technologies, L.l.c. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K990180 also covers:
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 |
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Manufacturer
- Manufacturer
- Water-Jel Technologies, L.l.c.
Sources (1)
- FDA UDI 49b9b408-05bf-4edb-9f35-f41ad892837c 36 fields · synced Jun 8, 2026