Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

1826NF

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 24, 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

ce799404-4278-4063-81a9-207a02be5254

Public Version Date

July 25, 2019

Public Version Number

5

DI Record Publish Date

August 20, 2016

Package DI Number

20809160002497

Quantity per Package

50

Contains DI Package

10809160002490

Package Discontinue Date

July 24, 2019

Package Status

Not in Commercial Distribution

Package Type

-