Catalog Number

-

Brand Name

Tampax

Version/Model Number

Tampax Cup

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

-

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

HHE

Product Code Name

Cup, menstrual

Public Device Record Key

1c0c3418-6c06-4b57-827d-b77b5f3b6da0

Public Version Date

September 07, 2021

Public Version Number

1

DI Record Publish Date

August 30, 2021

Package DI Number

10073010715360

Quantity per Package

12

Contains DI Package

00073010715301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case