Catalog Number

TCCLN004

Brand Name

2XChromosome

Version/Model Number

330201

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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

8f7bc759-ac94-4b90-be25-e72864c2f743

Public Version Date

August 01, 2022

Public Version Number

3

DI Record Publish Date

April 16, 2021

Package DI Number

10850022610049

Quantity per Package

12

Contains DI Package

00850022610042

Package Discontinue Date

December 31, 2021

Package Status

Not in Commercial Distribution

Package Type

-