DURA-GUARD Dural Repair Patch

FDA UDI

Class II (US FDA UDI)

by Synovis Life Technologies, Inc.

Identity

Trade Name: DURA-GUARD Dural Repair Patch FDA UDI
Generic Name: Dura mater graft, bovine FDA UDI
Device Name: DURA-GUARD Dural Repair Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. DURA-GUARD Dural Repair Patch is chemically sterilized using ethanol and propylene oxide. DURA-GUARD Dural Repair Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25 C. DURA-GUARD Dural Repair Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile. FDA UDI
Model / Reference: DG0608SN FDA UDI
Description: DURA-GUARD Dural Repair Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. DURA-GUARD Dural Repair Patch is chemically sterilized using ethanol and propylene oxide. DURA-GUARD Dural Repair Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25 C. DURA-GUARD Dural Repair Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile. FDA UDI

Identifiers

Catalog Number: DG0608SN FDA UDI
Primary DI / UDI-DI: 00085412531007 FDA UDI
FDA Product Code: GXQ FDA UDI
GMDN Term: Dura mater graft, bovine 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

Category: Dura mater graft, bovine

DURA-GUARD Dural Repair Patch by Synovis Life Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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DurAdapt — COLLAGEN MATRIX, INC. · Class II
Durepair™ — TEI BIOSCIENCES INC. · Class II
DuraGen® Plus — 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: Synovis Life Technologies, Inc.

Sources (1)

FDA UDI 206f768a-fd06-46ca-842a-935e839ba88d 36 fields · synced Jun 6, 2026