Catalog Number

-

Brand Name

Tampax

Version/Model Number

Tampax Pearl, Tampax Pocket 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

dc4d9456-f361-4086-802e-fbcaf9559c0d

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 20, 2018

Package DI Number

40037000028817

Quantity per Package

20

Contains DI Package

00037000028819

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pallet