DuraGen® Secure

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name: DuraGen® Secure FDA UDI
Generic Name: Dura mater biomatrix implant FDA UDI
Device Name: DuraGen® Secure Dural Regeneration Matrix 1 in*1 in 2.5 cm*2.5cm FDA UDI
Model / Reference: DRM1011 FDA UDI
Description: DuraGen® Secure Dural Regeneration Matrix 1 in*1 in 2.5 cm*2.5cm FDA UDI

Identifiers

Catalog Number: DRM1011 FDA UDI
Primary DI / UDI-DI: 10381780032489 FDA UDI
510(k) Number: K120600 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

Dimensions & Sizes

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

Category: Dura mater biomatrix implant

DuraGen® Secure by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dura mater biomatrix implant.

DuraMatrix Suturable — COLLAGEN MATRIX, INC. · Class II
DuraMend-Onlay™ Plus — COLLAGEN MATRIX, INC. · Class II
DuraMatrix Suturable — COLLAGEN MATRIX, INC. · Class II
DuraMatrix-Onlay Plus — COLLAGEN MATRIX, INC. · Class II
DuraMatrix-Onlay Plus — COLLAGEN MATRIX, INC. · Class II
DuraMend-Onlay™ Plus — COLLAGEN MATRIX, INC. · Class II
KBIO® Dura — COLLAGEN MATRIX, INC. · Class II
DURAFORM — Cerenovus, Inc. · Class II

Cleared under the same submission

K120600 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 II	Pending data

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Manufacturer

Manufacturer: Integra Lifesciences Corp.

Sources (1)

FDA UDI 91d79f01-d9c4-436c-b2c6-32c84c4085bf 38 fields · synced May 31, 2026