Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

9109

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 11, 2022

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Public Device Record Key

1060c4fc-67da-4ecf-937a-9fa6b4c01f07

Public Version Date

January 12, 2022

Public Version Number

5

DI Record Publish Date

August 20, 2016

Package DI Number

20809160003005

Quantity per Package

16

Contains DI Package

10809160003008

Package Discontinue Date

January 11, 2022

Package Status

Not in Commercial Distribution

Package Type

-