2XChromosome

Basic Information

• Brand Name: 2XChromosome
• Primary DI: 00850022610073
• Version / Model: 328201
• Catalog Number: TCCPN007
• Company Name: Global Health Solutions LLC
• Labeler DUNS: 117588619
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 14
• Record Status: Published
• Publish Date: 2021-04-16
• Public Version: 3
• Public Version Date: 2022-08-01
• Public Version Status: Update
• Public Device Record Key: 60b00f6e-3b8c-4a63-b94a-aeb15c213734
• Distribution End Date: 2021-12-31

Device Description

Cardboard Applicator Tampons Super Plus; individually wrapped, organic cotton absorbent core

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	884.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35694	Menstrual tampon, unscented	A non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood or other vaginal discharge. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850022610070	GS1		12	Not in Commercial Distribution	2021-12-31
Primary	00850022610073	GS1
Unit of Use	08432984001322	GS1