Suprathel®

FDA UDI

Class U (US FDA UDI)

by Polymedics Innovations, Inc.

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 18x23 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: 111823-US, 151823-US FDA UDI
Primary DI / UDI-DI: 04260184021437 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

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:

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: Polymedics Innovations, Inc.

Sources (1)

FDA UDI bcb0a24c-3c86-4b28-ba65-8a1d1d46802b 37 fields · synced May 30, 2026