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NeuraGen® 3D

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name
NeuraGen® 3D FDA UDI
Generic Name
Nerve guide, animal-derived FDA UDI
Device Name
NeuraGen Advanced Nerve Guide Matrix 7mm x 2cm FDA UDI
Model / Reference
PNGM720 FDA UDI
Description
NeuraGen Advanced Nerve Guide Matrix 7mm x 2cm FDA UDI

Identifiers

Catalog Number
PNGM720 FDA UDI
Primary DI / UDI-DI
10381780266778 FDA UDI
510(k) Number
K163457 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

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
Outer Diameter — 7 Millimeter FDA UDI
Length — 2 Centimeter FDA UDI

Category: Nerve guide, animal-derived

The NeuraGen 3D is a innovative medical device designed for nerve regeneration, making it an essential tool in hand surgery and nerve reconstruction.

Similar devices

Also classified as Nerve guide, animal-derived.

Cleared under the same submission

K163457 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra Lifesciences Corp.

Sources (1)

  • FDA UDI 67c668da-4858-4aa1-85f8-754327047328 38 fields · synced Jul 5, 2026