Identity
- Trade Name
- Duma+ Collagen Wound Dressing, 4" x 4" FDA UDI
- Generic Name
- Animal-derived wound matrix dressing FDA UDI
- Device Name
- Sterile-R FDA UDI
- Model / Reference
- 3097 FDA UDI
- Description
- Sterile-R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117343351 FDA UDI
- FDA Product Code
- KGN FDA UDI
- GMDN Term
- Animal-derived wound matrix 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
Yes
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
Yes
FDA UDI
Category: Animal-derived wound matrix dressing
Duma+ Collagen Wound Dressing, 4" x 4" by Dynarex Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Animal-derived wound matrix dressing.
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- Simpurity — SAFE N SIMPLE LLC · U
- ProgenaMatrix — Progenacare Global, LLC · 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 |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI 53feda2e-f063-4f01-a133-c2f44e7e6293 33 fields · synced May 31, 2026