Identity
- Trade Name
- Keramatrix FDA UDI
- Generic Name
- Keratin dressing FDA UDI
- Model / Reference
- KM-0203 FDA UDI
Identifiers
- Catalog Number
- KM-0203 FDA UDI
- Primary DI / UDI-DI
- 00850072068862 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Keratin dressing 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
No
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: Keratin dressing
Keramatrix by Biowound Solutions — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Keratin dressing.
- Keramatrix — BIOWOUND SOLUTIONS · U
- Keramatrix — BIOWOUND SOLUTIONS · U
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
- Biowound Solutions
Sources (1)
- FDA UDI b1b548f7-0b01-464b-bda8-ab61f9591b8e 33 fields · synced May 31, 2026