Identity
- Trade Name
- THERAFOAM FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- Therafoam Coated Wraps 1 Pack FDA UDI
- Model / Reference
- TRR-1 FDA UDI
- Description
- Therafoam Coated Wraps 1 Pack FDA UDI
Identifiers
- Catalog Number
- TRR-1 FDA UDI
- Primary DI / UDI-DI
- 00854763005990 FDA UDI
- 510(k) Number
- K991604 FDA UDI
- FDA Product Code
- MDA FDA UDI
- GMDN Term
- Scar-management dressing, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4025 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
Yes
FDA UDI
Category: Scar-management dressing, reusable
Therafoam by Biodermis Llc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biodermis Llc
Sources (2)
- FDA UDI fc269ba2-2b23-4a40-94b6-837d9f874b5b 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026