Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

69433

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

MCY

Product Code Name

Wound dressing kit

Public Device Record Key

3d1faf2d-471f-42e9-bcd7-720543647762

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 20, 2016

Package DI Number

20809160013691

Quantity per Package

30

Contains DI Package

10809160013694

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-