Identity
- Trade Name
- MIRRAGEN® Advanced Wound Matrix FDA UDI
- Generic Name
- Synthetic wound matrix dressing FDA UDI
- Device Name
- "Resorbable Borate Glass Wound Management Device" FDA UDI
- Model / Reference
- MWM-045-045 FDA UDI
- Description
- "Resorbable Borate Glass Wound Management Device" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812005030391 FDA UDI
- 510(k) Number
- K161067 FDA UDI
- FDA Product Code
- QSZ FDA UDI
- GMDN Term
- Synthetic 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
No
FDA UDI
Category: Synthetic wound matrix dressing
MIRRAGEN® Advanced Wound Matrix by Ets Wound Care Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic wound matrix dressing.
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- Suprathel® — Polymedics Innovations, Inc. · U
- Suprathel® — Polymedics Innovations, Inc. · U
- Suprathel® CW — Polymedics Innovations, Inc. · U
- SupraSDRM® — Polymedics Innovations, Inc. · U
Cleared under the same submission
K161067 also covers:
- MIRRAGEN® Advanced Wound Matrix — ETS WOUND CARE LLC
- MIRRAGEN® Advanced Wound Matrix — ETS WOUND CARE LLC
- MIRRAGEN® Advanced Wound Matrix — ETS WOUND CARE LLC
- MIRRAGEN® Advanced Wound Matrix — ETS WOUND CARE LLC
- MIRRAGEN® Advanced Wound Matrix — ETS WOUND CARE LLC
- MIRRASURG™ — ETS WOUND CARE LLC
- MIRRASURG™ — ETS WOUND CARE LLC
- MIRRASURG™ — ETS WOUND CARE LLC
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
- Ets Wound Care Llc
Sources (1)
- FDA UDI bcd092b9-059b-4c48-b667-743087674a8a 35 fields · synced Jun 1, 2026