Catalog Number

-

Brand Name

Playtex

Version/Model Number

08258

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

78df4977-c5a8-4452-af67-390cc3b4f419

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

March 03, 2020

Package DI Number

10078300082580

Quantity per Package

2

Contains DI Package

20078300082587

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-