AxoGuard Nerve Cap - The AxoGuard® Nerve Cap is a surgical implant - AXOGEN CORPORATION

Duns Number:113424464

Device Description: The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the surrounding soft tissue bed by pulling the nerve into the tube and suturing the nerve within the cap. The end of the cap has a suturable tab to allow the surgeon to suture the device to surrounding tissue. AxoGuard® Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, AxoGuard® Nerve Cap is easy to handle, soft, pliable, nonfriable and porous. AxoGuard® Nerve Cap is flexible and pliable to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized non-absorbable suture. AxoGuard® Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.

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More Product Details

Catalog Number

-

Brand Name

AxoGuard Nerve Cap

Version/Model Number

AGT720

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

-

Product Code Details

Product Code

JXI

Product Code Name

Cuff, Nerve

Device Record Status

Public Device Record Key

62b10d43-041c-4156-91d7-1bc92df04bdb

Public Version Date

December 08, 2021

Public Version Number

4

DI Record Publish Date

October 24, 2017

Additional Identifiers

Package DI Number

10850828007098

Quantity per Package

1

Contains DI Package

00850828007091

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"AXOGEN CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 2