Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

76879

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

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

4e59d81e-565a-435e-8e0b-75414332b5ff

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 01, 2017

Package DI Number

20809160130541

Quantity per Package

8

Contains DI Package

10809160130544

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-