Identity
- Trade Name
- MiroDerm Fenestrated Plus FDA UDI
- Generic Name
- Animal-derived wound matrix dressing FDA UDI
- Device Name
- 3 x 7 cm Fenestrated Plus Biologic Wound Matrix FDA UDI
- Model / Reference
- BLM-200-03-0307 FDA UDI
- Description
- 3 x 7 cm Fenestrated Plus Biologic Wound Matrix FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857072005224 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
- Not 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
No
FDA UDI
MR Safe FDA UDI
MiroDerm Fenestrated Plus by Reprise Biomedical, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Reprise Biomedical, Inc.
Sources (1)
- FDA UDI a4fdae5b-e9a0-48af-8872-46467c5b6bc7 35 fields · synced May 30, 2026