Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

58528

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 09, 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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FKG

Product Code Name

TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS

Public Device Record Key

d99948af-2181-4ecd-9cbb-8244229a95f4

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

August 20, 2016

Package DI Number

20809160008543

Quantity per Package

20

Contains DI Package

10809160008546

Package Discontinue Date

November 09, 2021

Package Status

Not in Commercial Distribution

Package Type

-