Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

79350

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)

-

Over the Counter (OTC)

Yes

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

38ff5911-e8ae-4241-8530-68e976d0b331

Public Version Date

October 02, 2019

Public Version Number

1

DI Record Publish Date

September 24, 2019

Package DI Number

20809160264093

Quantity per Package

50

Contains DI Package

10809160264096

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-