NeuraWrap®

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name: NeuraWrap® FDA UDI
Generic Name: Nerve guide, animal-derived FDA UDI
Device Name: NeuraWrap® Nerve Protector 7mm I.D. X 4cm Length FDA UDI
Model / Reference: NW740 FDA UDI
Description: NeuraWrap® Nerve Protector 7mm I.D. X 4cm Length FDA UDI

Identifiers

Catalog Number: NW740 FDA UDI
Primary DI / UDI-DI: 10381780026457 FDA UDI
510(k) Number: K041620 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 — 4 Centimeter FDA UDI

Category: Nerve guide, animal-derived

NeuraWrap® by Integra Lifesciences Corp. — 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
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
Checkpoint Nerve Repair Kit — Checkpoint Surgical, Inc.

Cleared under the same submission

K041620 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: Integra Lifesciences Corp.

Sources (1)

FDA UDI fd637796-3e5a-40b3-bc7b-e762ce3a138e 38 fields · synced May 31, 2026