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DuraMend-Onlay™ Plus

FDA UDI

Class II (US FDA UDI)

by Collagen Matrix, Inc.

Identity

Trade Name
DuraMend-Onlay™ Plus FDA UDI
Generic Name
Dura mater biomatrix implant FDA UDI
Device Name
Collagen Dural Regeneration Matrix 1in x 3in (2.5cm x 7.5cm) FDA UDI
Model / Reference
NDMOP13 FDA UDI
Description
Collagen Dural Regeneration Matrix 1in x 3in (2.5cm x 7.5cm) FDA UDI

Identifiers

Primary DI / UDI-DI
00813954022277 FDA UDI
FDA Product Code
GXQ FDA UDI
GMDN Term
Dura mater biomatrix implant FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5910 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Length — 3 Inch FDA UDI
Width — 1 Inch FDA UDI

Category: Dura mater biomatrix implant

DuraMend-Onlay™ Plus by Collagen Matrix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dura mater biomatrix implant.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Collagen Matrix, Inc.

Sources (1)

  • FDA UDI 798c5498-8ea8-410a-aa81-ab18d6fb9109 34 fields · synced Jun 8, 2026