Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

41212

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

6f6921a5-dbab-4605-b0a8-cb79655d6e4e

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

August 20, 2016

Package DI Number

30809160000896

Quantity per Package

50

Contains DI Package

10809160000892

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-