FC2 271594

GUDID 10861783000116

FC2 Female Condom

Female Health Company

Female condom, synthetic polymer

• Primary Device ID: 10861783000116
• NIH Device Record Key: 2602f554-b7aa-49ec-baca-7b80d309ffe6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FC2
• Version Model Number: 271594
• Catalog Number: 271594
• Company DUNS: 055300578
• Company Name: Female Health Company
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.com

Device Dimensions

• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter
• Length: 170 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00000000000000 [Unit of Use]
GS1	00861783000102 [Unit of Use]
GS1	00861783000119 [Primary]
GS1	10861783000116 [Package]; Contains: 00861783000119; Package: Case [240 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080002

FDA Product Code

• MBU: Condom, female, single-use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [FC2]

• 10861783000116: FC2 Female Condom
• 40861783000100: FC2 Female Condom