Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

78938

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

e69950b7-e3ca-4217-9325-049c83106e3a

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

January 23, 2019

Package DI Number

20809160224530

Quantity per Package

10

Contains DI Package

10809160224533

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-