Catalog Number

AGX115

Brand Name

AxoGuard

Version/Model Number

G35128

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K031069,K162741,K031069,K162741

Product Code

JXI

Product Code Name

CUFF, NERVE

Public Device Record Key

2aa38173-e3d2-40c5-886b-80df1a33d6ac

Public Version Date

March 25, 2022

Public Version Number

6

DI Record Publish Date

November 03, 2015

Package DI Number

10827002351285

Quantity per Package

1

Contains DI Package

00827002351288

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-