Catalog Number

PBORN002

Brand Name

2XChromosome

Version/Model Number

(2X)200920

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

HHD

Product Code Name

Pad, Menstrual, Unscented

Public Device Record Key

26babdbc-218e-4573-85d9-8f4c3d7d5fac

Public Version Date

August 01, 2022

Public Version Number

2

DI Record Publish Date

April 30, 2021

Package DI Number

10850022610025

Quantity per Package

48

Contains DI Package

00850022610028

Package Discontinue Date

December 31, 2021

Package Status

Not in Commercial Distribution

Package Type

-