Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

68330B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 19, 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)

-

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

-

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

-

FDA Premarket Submission

-

Product Code

KDD

Product Code Name

Kit, surgical instrument, disposable

Public Device Record Key

984a3f03-2f32-4b5a-8929-bc6cbfd997d9

Public Version Date

December 20, 2019

Public Version Number

3

DI Record Publish Date

August 20, 2016

Package DI Number

20809160022877

Quantity per Package

20

Contains DI Package

10809160022870

Package Discontinue Date

December 19, 2019

Package Status

Not in Commercial Distribution

Package Type

-