Catalog Number

-

Brand Name

U by Kotex

Version/Model Number

Pad

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2022

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"

-

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

HHD

Product Code Name

Pad, menstrual, unscented

Public Device Record Key

b82439d2-a0e3-4654-ad82-38287357840e

Public Version Date

September 30, 2022

Public Version Number

3

DI Record Publish Date

July 01, 2020

Package DI Number

00036000490619

Quantity per Package

6

Contains DI Package

00036000010039

Package Discontinue Date

September 30, 2022

Package Status

Not in Commercial Distribution

Package Type

Case