NeuroMatrix

FDA UDI

Class II (US FDA UDI)

by Collagen Matrix, Inc.

Identity

Trade Name: NeuroMatrix FDA UDI
Generic Name: Nerve guide, animal-derived FDA UDI
Device Name: Collagen Nerve Cuff 5mm (inner diameter) x 2.5cm (length) FDA UDI
Model / Reference: CNC5025 FDA UDI
Description: Collagen Nerve Cuff 5mm (inner diameter) x 2.5cm (length) FDA UDI

Identifiers

Primary DI / UDI-DI: 00813954020044 FDA UDI
510(k) Number: K012814 FDA UDI
FDA Product Code: JXI FDA UDI
GMDN Term: Nerve guide, animal-derived FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5275 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 — 2.5 Centimeter FDA UDI
Lumen/Inner Diameter — 5 Millimeter FDA UDI

Category: Nerve guide, animal-derived

NeuroMatrix by Collagen Matrix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nerve guide, animal-derived.

AxoGuard — COOK BIOTECH INCORPORATED · Class II
NeuraGen® — Integra Lifesciences Corp. · Class II
AxoGuard — COOK BIOTECH INCORPORATED · Class II
AxoGuard — COOK BIOTECH INCORPORATED · Class II
AxoGuard Nerve Cap — AxoGen Corporation · Class II
ConformaWrap — Biocircuit Technologies, Inc. · Class II
Checkpoint Nerve Repair Kit — Checkpoint Surgical, Inc.
NeuraGen® — Integra Lifesciences Corp. · Class II

Cleared under the same submission

K012814 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: Collagen Matrix, Inc.

Sources (1)

FDA UDI b9a42cd7-4c03-4d8e-8c2f-b3a72589712c 35 fields · synced Jun 8, 2026