Catalog Number

Not Applicable

Brand Name

MedSource Gauze

Version/Model Number

MS-GZ2212S

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

17f531cd-481c-46b6-8573-246f428b4214

Public Version Date

December 28, 2021

Public Version Number

3

DI Record Publish Date

August 03, 2021

Package DI Number

00816703028902

Quantity per Package

1500

Contains DI Package

00816703028896

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case