Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

79503

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

-

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

9b042eb3-4422-497b-be80-6b9943d2c968

Public Version Date

August 30, 2019

Public Version Number

1

DI Record Publish Date

August 22, 2019

Package DI Number

20809160255756

Quantity per Package

20

Contains DI Package

10809160255759

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-