Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

76435

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2017

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

OIE

Product Code Name

Urine collection kit (excludes HIV testing)

Public Device Record Key

1f2d3fea-e1b7-499a-af5f-b7ee6143e69f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 28, 2016

Package DI Number

20809160107291

Quantity per Package

20

Contains DI Package

10809160107294

Package Discontinue Date

August 31, 2017

Package Status

Not in Commercial Distribution

Package Type

-