Identity
- Trade Name
- Suprathel® FDA UDI
- Generic Name
- Synthetic wound matrix dressing FDA UDI
- Device Name
- Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treatment of wounds, split-skin donor sites, and burns as indicated hereinafter. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient’s needs. FDA UDI
- Model / Reference
- Suprathel 9x10 FDA UDI
- Description
- Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treatment of wounds, split-skin donor sites, and burns as indicated hereinafter. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient’s needs. FDA UDI
Identifiers
- Catalog Number
- 110910-US, 150910-US FDA UDI
- Primary DI / UDI-DI
- 04260184021239 FDA UDI
- 510(k) Number
- K090160 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
Suprathel® by Polymedics Innovations, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic wound matrix dressing.
- SiOxD Wound Matrix — Sioxmed, LLC · U
- NovoSorb MTX — Polynovo Biomaterials Pty, Ltd. · U
- NovoSorb BTM — Polynovo Biomaterials Pty, Ltd. · U
- MIRRASURG™ — ETS WOUND CARE LLC · U
- MIRRAGEN® Advanced Wound Matrix — ETS WOUND CARE LLC · U
- MIRRAGEN® Advanced Wound Matrix — ETS WOUND CARE LLC · U
- Restrata MiniMatrix — Acera Surgical Inc · U
- Restrata Wound Matrix — Acera Surgical Inc · U
Cleared under the same submission
K090160 also covers:
- Suprathel® — Polymedics Innovations, Inc.
- Suprathel® — Polymedics Innovations, Inc.
- Suprathel® — Polymedics Innovations, Inc.
- Suprathel® — Polymedics Innovations, Inc.
- Suprathel® — Polymedics Innovations, Inc.
- Suprathel® CW — Polymedics Innovations, Inc.
- Suprathel® CW — Polymedics Innovations, Inc.
- Suprathel® CW — Polymedics Innovations, Inc.
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
- Polymedics Innovations, Inc.
Sources (1)
- FDA UDI 43010e85-e353-40fd-906d-02e17fb36c70 37 fields · synced May 30, 2026