Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

79256

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 08, 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

Yes

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

-

FDA Premarket Submission

-

Product Code

OVN

Product Code Name

Suture kit

Public Device Record Key

475ba713-4b7a-4075-9f1e-9f744f7ae31a

Public Version Date

November 11, 2019

Public Version Number

2

DI Record Publish Date

May 10, 2019

Package DI Number

20809160239022

Quantity per Package

20

Contains DI Package

10809160239025

Package Discontinue Date

November 08, 2019

Package Status

Not in Commercial Distribution

Package Type

-