Catalog Number

Not Applicable

Brand Name

MedSource Gauze

Version/Model Number

MS-GZCS4

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

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

ae417633-00ef-4ffc-a6b3-cdfff484c910

Public Version Date

December 28, 2021

Public Version Number

3

DI Record Publish Date

August 03, 2021

Package DI Number

00840155412033

Quantity per Package

96

Contains DI Package

00840155411951

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case