Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

9108

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Public Device Record Key

98249e6a-14a1-446b-aaec-2f10235915ce

Public Version Date

October 21, 2020

Public Version Number

4

DI Record Publish Date

August 20, 2016

Package DI Number

20809160002992

Quantity per Package

16

Contains DI Package

10809160002995

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-