Catalog Number

-

Brand Name

U By Kotex

Version/Model Number

Tampon

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

K141294

Product Code

HEB

Product Code Name

Tampon, menstrual, unscented

Public Device Record Key

d90e7b6a-b710-4a1e-9f8c-37ef567143ef

Public Version Date

September 30, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-