Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

75865

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 05, 2019

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NSB

Product Code Name

Patient personal hygiene kit

Public Device Record Key

57ca2c78-a2d1-48ef-858e-8e275c440131

Public Version Date

July 08, 2019

Public Version Number

3

DI Record Publish Date

September 27, 2016

Package DI Number

20809160107253

Quantity per Package

8

Contains DI Package

10809160107256

Package Discontinue Date

July 05, 2019

Package Status

Not in Commercial Distribution

Package Type

-