Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

70484

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 09, 2019

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

KKX

Product Code Name

Drape, surgical

Public Device Record Key

1dc3f55b-b037-4fd0-9d0e-899de0137a4a

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

August 20, 2016

Package DI Number

20809160014902

Quantity per Package

20

Contains DI Package

10809160014905

Package Discontinue Date

July 09, 2019

Package Status

Not in Commercial Distribution

Package Type

-