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KBIO® Dura

FDA UDI

Class II (US FDA UDI)

by Collagen Matrix, Inc.

Identity

Trade Name
KBIO® Dura FDA UDI
Generic Name
Dura mater biomatrix implant FDA UDI
Device Name
Dural Repair Collagen Matrix 75 x 75 75 x 75mm (3 x 3in) FDA UDI
Model / Reference
KBI-DU 03 03-S FDA UDI
Description
Dural Repair Collagen Matrix 75 x 75 75 x 75mm (3 x 3in) FDA UDI

Identifiers

Primary DI / UDI-DI
00813954023809 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
Width — 75 Millimeter FDA UDI
Length — 75 Millimeter FDA UDI

Category: Dura mater biomatrix implant

KBIO® Dura 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 af0a799f-bff8-4ce2-a009-1767c1dbb093 34 fields · synced Jun 8, 2026