Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

52909

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 06, 2020

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

3a4d9c28-715c-4efa-b7ca-1c49df1e8a02

Public Version Date

April 24, 2020

Public Version Number

2

DI Record Publish Date

March 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-