Catalog Number

-

Brand Name

ALL TERRAIN

Version/Model Number

608503050074

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAB

Product Code Name

Gauze / Sponge,Nonresorbable For External Use

Public Device Record Key

54ca64ee-a539-484f-b39a-36b279c57051

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

December 16, 2020

Package DI Number

10608503050071

Quantity per Package

72

Contains DI Package

00608503050074

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case