Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

710-B

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

-

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

e0bcfcf1-0101-495c-8ccc-9c0aa19f7ea1

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

August 20, 2016

Package DI Number

20809160015589

Quantity per Package

8

Contains DI Package

10809160015582

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-