Catalog Number

-

Brand Name

FEMTEX

Version/Model Number

FT11804UA/FT11812UO

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)

-

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

70225362-ddf1-4d88-86e8-c2b89afe4fb2

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

August 16, 2016

Package DI Number

20748364102049

Quantity per Package

4

Contains DI Package

00748364102045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Container