Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

81891

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

K970889,K970889

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

cf4474df-8a07-4a47-acea-b1bc357094a0

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

July 27, 2021

Package DI Number

20809160355630

Quantity per Package

20

Contains DI Package

10809160355633

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-