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 5in x 7in (12.5cm x 17.5cm) FDA UDI
Model / Reference: NDMOP57 FDA UDI
Description: Collagen Dural Regeneration Matrix 5in x 7in (12.5cm x 17.5cm) FDA UDI

Identifiers

Primary DI / UDI-DI: 00813954022314 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

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

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 7 Inch FDA UDI
Width — 5 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.

DuraGen® Plus — Integra Lifesciences Corp. · Class II
DuraGen® Secure — Integra Lifesciences Corp. · Class II
DuraGen® — Integra Lifesciences Corp. · Class II
DURAFORM — Cerenovus, Inc. · Class II
DURASIS — COOK BIOTECH INCORPORATED · Class II
Biodesign — COOK BIOTECH INCORPORATED · Class II
DURAFORM — Natus Medical Incorporated · Class II
DuraGen® Suturable — Integra Lifesciences Corp. · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Collagen Matrix, Inc.

Sources (1)

FDA UDI a1e68b60-a105-4d2c-b123-41e731f71a75 34 fields · synced Jun 8, 2026