Restrata MiniMatrix

FDA UDI

Class U (US FDA UDI)

by Acera Surgical Inc

Identity

Trade Name: Restrata MiniMatrix FDA UDI
Generic Name: Synthetic wound matrix dressing FDA UDI
Model / Reference: RMINI-1000 FDA UDI

Identifiers

Primary DI / UDI-DI: 00854258006341 FDA UDI
510(k) Number: K223725 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Synthetic wound matrix dressing

Restrata MiniMatrix by Acera Surgical 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
Suprathel® — Polymedics Innovations, Inc. · U
NovoSorb MTX — Polynovo Biomaterials Pty, Ltd. · U
NovoSorb BTM — Polynovo Biomaterials Pty, Ltd. · U
MIRRASURG™ — ETS WOUND CARE LLC · U
Suprathel® — Polymedics Innovations, Inc. · U
Suprathel® — Polymedics Innovations, Inc. · U
MIRRAGEN® Advanced Wound Matrix — ETS WOUND CARE LLC · U

Cleared under the same submission

K223725 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Acera Surgical Inc

Sources (1)

FDA UDI d73a7abf-e769-45aa-aa1c-664d672321be 33 fields · synced Jun 6, 2026