Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

79506

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)

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

KDD

Product Code Name

Kit, surgical instrument, disposable

Public Device Record Key

a3b265bb-99cb-402b-83ef-00c28f91ce41

Public Version Date

July 26, 2019

Public Version Number

1

DI Record Publish Date

July 18, 2019

Package DI Number

20809160246846

Quantity per Package

20

Contains DI Package

10809160246849

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-