TROJAN™ NaturaLamb™ Luxury Condoms

Basic Information

• Brand Name: TROJAN™ NaturaLamb™ Luxury Condoms
• Primary DI: 00022600980506
• Version / Model: 00022600980506
• Company Name: CHURCH & DWIGHT CO., INC.
• Labeler DUNS: 001211952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-10-13
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 448de2d2-76ba-434e-8954-23992444d766

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: Yes
• 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
60379	Basic male condom, animal-derived	A sheath made from animal-derived materials (e.g., lambskin) intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract. It is indicated only for the prevention of pregnancy and not for the prevention of sexually transmitted infections (STI) and typically contains lubricants. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00022600980506	GS1
Unit of Use	80022600980502	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K901202	000