Checkpoint NeuroShield Chitosan Membrane

FDA UDI

Class II (US FDA UDI)

by Checkpoint Surgical, Inc.

Identity

Trade Name: Checkpoint NeuroShield Chitosan Membrane FDA UDI
Generic Name: Nerve guide, animal-derived FDA UDI
Device Name: NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries. FDA UDI
Model / Reference: NS3020 FDA UDI
Description: NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries. FDA UDI

Identifiers

Catalog Number: NS3020 FDA UDI
Primary DI / UDI-DI: B130NS30200 FDA UDI
510(k) Number: K190246 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

Checkpoint NeuroShield Chitosan Membrane by Checkpoint Surgical, 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
NeuroFlex — COLLAGEN MATRIX, INC. · Class II
NeuroMatrix — COLLAGEN MATRIX, INC. · Class II
AxoGuard — COOK BIOTECH INCORPORATED · Class II
AxoGuard Nerve Cap — AxoGen Corporation · Class II
ConformaWrap — Biocircuit Technologies, Inc. · Class II

Cleared under the same submission

K190246 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: Checkpoint Surgical, Inc.

Sources (1)

FDA UDI a15e54da-e19d-4647-b409-4ef1fbe655df 37 fields · synced May 29, 2026