Nerbridge® - Nerbridge® is a product composed of polyglycolic - TOYOBO CO., LTD.

Duns Number:690538160

Device Description: Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine sk Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine skin. Nerbridge® is a flexible, resorbable and semipermeable tubular membrane matrix filled with porous collagen that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Nerbridge® is designed to be an interface between the nerve and the surrounding tissue. When hydrated, Nerbridge® is an easy to handle, pliable, soft, non-friable, porous conduit. The resilience of Nerbridge® allows the product to recover and maintain closure without constricting the nerve once the device is placed around the nerve. Nerbridge® is manufactured using validated viral inactivation and removal processes for the collagen. The product is provided in a foil pouch, sterile, non-pyrogenic, for single use only, in a variety of sizes, and placed in an outer Tyvek header bag for added protection.

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More Product Details

Catalog Number

RN03525E

Brand Name

Nerbridge®

Version/Model Number

RN03525E

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 08, 2018

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"

-

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

K152967

Product Code Details

Product Code

JXI

Product Code Name

Cuff, Nerve

Device Record Status

Public Device Record Key

01e43405-4a20-4a71-b755-87259330cbd8

Public Version Date

May 12, 2022

Public Version Number

4

DI Record Publish Date

July 27, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TOYOBO CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7