Catalog Number

-

Brand Name

Playtex

Version/Model Number

08254

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

K111684,K111684,K111684

Product Code

HEB

Product Code Name

Tampon, menstrual, unscented

Public Device Record Key

329f15b9-48e7-40bf-a2c4-4c74fe1a5a1b

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 03, 2020

Package DI Number

10078300082542

Quantity per Package

4

Contains DI Package

20078300082549

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-