AxoGuard

FDA UDI

Class II (US FDA UDI)

by Cook Biotech Incorporated

Identity

Trade Name: AxoGuard FDA UDI
Generic Name: Nerve guide, animal-derived FDA UDI
Device Name: AxoGuard Nerve Connector FDA UDI
Model / Reference: G52796 FDA UDI
Description: AxoGuard Nerve Connector FDA UDI

Identifiers

Catalog Number: AGX410 FDA UDI
Primary DI / UDI-DI: 00827002527966 FDA UDI
510(k) Number: K031069 FDA UDI
K162741 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

MRI Safety

MR Safe FDA UDI

Category: Nerve guide, animal-derived

AxoGuard by Cook Biotech Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nerve guide, animal-derived.

NeuraGen® — Integra Lifesciences Corp. · Class II
NeuroFlex — COLLAGEN MATRIX, INC. · Class II
NeuroMatrix — COLLAGEN MATRIX, INC. · Class II
AxoGuard Nerve Cap — AxoGen Corporation · Class II
ConformaWrap — Biocircuit Technologies, Inc. · Class II
Checkpoint Nerve Repair Kit — Checkpoint Surgical, Inc.
NeuroMatrix — COLLAGEN MATRIX, INC. · Class II
NeuraGen® — Integra Lifesciences Corp. · Class II

Cleared under the same submission

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: Cook Biotech Incorporated

Sources (1)

FDA UDI 28455cfa-89c4-4df3-8dc3-74a7ec8ab6b9 37 fields · synced Jun 1, 2026