Troj Variety Pack BareSkin

Basic Information

• Brand Name: Troj Variety Pack BareSkin
• Primary DI: 00022600001577
• Version / Model: 00022600001577
• Company Name: CHURCH & DWIGHT CO., INC.
• Labeler DUNS: 001211952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2021-10-26
• Public Version: 1
• Public Version Date: 2021-11-03
• Public Version Status: New
• Public Device Record Key: 3d0fe622-8e6a-4636-91c6-f5458eb88b2b

Device Description

For Contraception Plus STI Protection

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIS	CONDOM	Obstetrics/Gynecology	884.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54138	Dehydroepiandrosterone (DHEA) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is intended to be used for the quantitative measurement of dehydroepiandrosterone (DHEA) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	80022600001573	GS1
Primary	00022600001577	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K090259	000
K141256	000
K192669	000