Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

72324

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 22, 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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

OFA

Product Code Name

Cardiovascular surgical instruments tray

Public Device Record Key

f6b94ad8-cd9b-49ec-a531-7f43da020e4b

Public Version Date

March 11, 2019

Public Version Number

3

DI Record Publish Date

August 20, 2016

Package DI Number

20809160017453

Quantity per Package

20

Contains DI Package

10809160017456

Package Discontinue Date

February 22, 2019

Package Status

Not in Commercial Distribution

Package Type

-