Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

68170

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 15, 2021

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

f482c949-ad6d-4feb-8470-e21eed1ac360

Public Version Date

October 18, 2021

Public Version Number

4

DI Record Publish Date

August 20, 2016

Package DI Number

20809160012120

Quantity per Package

50

Contains DI Package

10809160012123

Package Discontinue Date

October 15, 2021

Package Status

Not in Commercial Distribution

Package Type

-