Catalog Number

-

Brand Name

Playtex

Version/Model Number

08111

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K060981,K060981,K060981

Product Code

HEB

Product Code Name

TAMPON, MENSTRUAL, UNSCENTED

Public Device Record Key

6d781209-fefe-4458-8383-c2850dc3d003

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

April 01, 2019

Package DI Number

10078300081118

Quantity per Package

2

Contains DI Package

20078300081115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-