Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

81391

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 27, 2020

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

3f181c8a-14e3-42e3-acc5-c84ccee471ab

Public Version Date

October 28, 2020

Public Version Number

2

DI Record Publish Date

July 07, 2020

Package DI Number

20809160286729

Quantity per Package

20

Contains DI Package

10809160286722

Package Discontinue Date

October 27, 2020

Package Status

Not in Commercial Distribution

Package Type

-