Identity
- Trade Name
- XeroBurn Sterile Burn Dressings, 4" x 4" FDA UDI
- Generic Name
- Synthetic polymer burn dressing, gel-coated FDA UDI
- Device Name
- STERILE-R FDA UDI
- Model / Reference
- 1295BULK FDA UDI
- Description
- STERILE-R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117332898 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
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
No
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
Yes
FDA UDI
Category: Synthetic polymer burn dressing, gel-coated
XeroBurn Sterile Burn Dressings, 4" x 4" by Dynarex Corp. — 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
- BurnFree — WATER-JEL TECHNOLOGIES, L.L.C. · Class I
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- First Responder — WATER-JEL TECHNOLOGIES, L.L.C. · 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
- Dynarex Corp.
Sources (1)
- FDA UDI 84869ff8-b290-4b96-8b9d-0c636a6b5861 33 fields · synced May 30, 2026