NeuraWrap™ - NEURAWRAP 10MM NERVE PROTECTORThe NeuraWrap Nerve - Integra Lifesciences Corporation

Duns Number:083171244

Device Description: NEURAWRAP 10MM NERVE PROTECTORThe NeuraWrap Nerve Protector is an absorbable collagen impl NEURAWRAP 10MM NERVE PROTECTORThe NeuraWrap Nerve Protector is an absorbable collagen implant that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. It is designed to be an interface between the nerve and the surrounding tissue. When hydrated, the NeuraWrap nerve protector is an easy to handle, soft, pliable, nonfriable, porous collagen conduit. The wall of the conduit has a longitudinal slit that allows NeuraWrap nerve protector to be spread open for easy placement over the injured nerve. The resilience of the collagen conduit allows NeuraWrap nerve protector to recover and maintain closure once the device is placed around the nerve.

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More Product Details

Catalog Number

NW1020

Brand Name

NeuraWrap™

Version/Model Number

NW1020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K041620

Product Code Details

Product Code

JXI

Product Code Name

CUFF, NERVE

Device Record Status

Public Device Record Key

0df1f347-789e-418c-936b-a161b110e561

Public Version Date

October 25, 2022

Public Version Number

5

DI Record Publish Date

September 22, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA LIFESCIENCES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 75
3 A medical device with high risk that requires premarket approval 17
U Unclassified 32