Catalog Number

-

Brand Name

U by Kotex

Version/Model Number

Tampon

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2021

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

HEB

Product Code Name

TAMPON, MENSTRUAL, UNSCENTED

Public Device Record Key

22bcc4de-28c7-4953-9f28-22ca956bc56f

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

March 26, 2019

Package DI Number

10036000376972

Quantity per Package

6

Contains DI Package

00036000376975

Package Discontinue Date

July 01, 2021

Package Status

Not in Commercial Distribution

Package Type

Case