Catalog Number

-

Brand Name

TAMPON TRIBE

Version/Model Number

Size L

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

edbde083-3c56-44d5-adfa-921ce3937ea7

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

March 31, 2020

Package DI Number

00640816981379

Quantity per Package

6

Contains DI Package

00640816981348

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master carton