Catalog Number

-

Brand Name

Tampax

Version/Model Number

Tampax Pearl

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

fd5fdf65-d9af-40e7-b36c-8d18a0ce5957

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

December 13, 2019

Package DI Number

40037000118914

Quantity per Package

12

Contains DI Package

00037000118916

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pallet