Catalog Number

-

Brand Name

ALL TERRAIN

Version/Model Number

608503050081

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

f01d491f-01dc-48f2-b5db-cd21c634e483

Public Version Date

December 24, 2020

Public Version Number

1

DI Record Publish Date

December 16, 2020

Package DI Number

10608503050088

Quantity per Package

72

Contains DI Package

00608503050081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case