Restrata™ Wound Matrix

FDA UDI

Class U (US FDA UDI)

by Acera Surgical Inc

Identity

Trade Name: Restrata™ Wound Matrix FDA UDI
Generic Name: Bioabsorbable wound dressing FDA UDI
Device Name: The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body’s natural healing process to occur. FDA UDI
Model / Reference: RWM1-4X5 FDA UDI
Description: The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body’s natural healing process to occur. FDA UDI

Identifiers

Primary DI / UDI-DI: 00854258006112 FDA UDI
FDA Product Code: FRO FDA UDI
GMDN Term: Bioabsorbable wound 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

Dimensions & Sizes

Size: Width — 10 Centimeter FDA UDI
Length — 12.5 Centimeter FDA UDI

Category: Bioabsorbable wound dressing

Restrata™ Wound Matrix by Acera Surgical Inc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bioabsorbable wound dressing.

CovoraTM — Acera Surgical Inc · U
Restrata™ Wound Matrix — Acera Surgical Inc · U
CovoraTM — Acera Surgical Inc · U
Restrata™ Wound Matrix — Acera Surgical Inc · U
Restrata™ Wound Matrix — Acera Surgical Inc · U
CovoraTM — Acera Surgical Inc · U
Restrata™ Wound Matrix — Acera Surgical Inc · U
Restrata(R) — Acera Surgical Inc · U

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 a2148459-c43f-4073-b632-591872036219 34 fields · synced May 31, 2026