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Restrata Meshed

FDA UDI

Class U (US FDA UDI)

by Acera Surgical Inc

Identity

Trade Name
Restrata Meshed FDA UDI
Generic Name
Synthetic wound matrix dressing FDA UDI
Device Name
The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds. FDA UDI
Model / Reference
RMESH-3X3 FDA UDI
Description
The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds. FDA UDI

Identifiers

Primary DI / UDI-DI
00854258006280 FDA UDI
FDA Product Code
FRO 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Synthetic wound matrix dressing

Restrata Meshed 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Acera Surgical Inc

Sources (1)

  • FDA UDI c5a877f6-12ed-4909-96d9-436ddddaf130 33 fields · synced Jun 6, 2026