FC2

Basic Information

• Brand Name: FC2
• Primary DI: 00861783000119
• Version / Model: 271594
• Catalog Number: 271594
• Company Name: Veru Inc.
• Labeler DUNS: 055300578
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 6
• Public Version Date: 2021-08-11
• Public Version Status: Update
• Public Device Record Key: 2602f554-b7aa-49ec-baca-7b80d309ffe6
• Distribution End Date: 2017-02-13

Device Description

FC2 Female Condom

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• 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
MBU	Condom, female, single-use	Obstetrics/Gynecology	884.5340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47722	Female condom, synthetic polymer	A sheath made of synthetic polymers (e.g., polyurethane or nitrile) with rings on either end that is inserted into the vagina before coitus to prevent sperm from gaining access to the female reproductive tract and/or to prevent the transmission of sexually transmitted infections (STI) between sexual partners. It typically includes a lubricant to minimize friction during coitus. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10861783000116	GS1	Case	240	Not in Commercial Distribution	2017-02-13
Primary	00861783000119	GS1
Unit of Use	00861783000102	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P080002	000

Device Sizes

Type	Value	Unit	Text
Length	170	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool dry place away from direct sunlight