FC2 121107

GUDID 40861783000100

FC2 Female Condom

Female Health Company

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• Primary Device ID: 40861783000100
• NIH Device Record Key: fd5bdde7-7ee1-4922-829f-a1dc35f7533c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FC2
• Version Model Number: 121107
• Catalog Number: 121107
• Company DUNS: 055300578
• Company Name: Female Health Company
• Device Count: 100
• 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.
• Phone: +1(312)595-9123
• Email: bannonson@femalehealthcompany.
• 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: 312-968-4713
• Email: Kgilbert@verupharma.com
• Phone: 312-968-4713
• Email: Kgilbert@verupharma.com
• Phone: 312-968-4713
• Email: Kgilbert@verupharma.com
• Phone: 312-968-4713
• Email: Kgilbert@verupharma.com
• Phone: 312-968-4713
• Email: Kgilbert@verupharma.com
• Phone: 312-968-4713
• Email: Kgilbert@verupharma.com
• Phone: 312-968-4713
• Email: Kgilbert@verupharma.com
• Phone: 312-968-4713
• Email: Kgilbert@verupharma.com
• Phone: 312-968-4713
• Email: Kgilbert@verupharma.com
• Phone: 312-968-4713
• Email: Kgilbert@verupharma.com
• Phone: 312-968-4713
• Email: Kgilbert@verupharma.com
• Phone: 312-968-4713
• Email: Kgilbert@verupharma.com
• Phone: 312-968-4713
• Email: Kgilbert@verupharma.com
• Phone: 312-968-4713
• Email: Kgilbert@verupharma.com
• Phone: 312-968-4713
• Email: Kgilbert@verupharma.com
• Phone: 312-968-4713
• Email: Kgilbert@verupharma.com
• Phone: +1(312)968-4713
• Email: Kgilbert@verupharma.com
• Phone: +1(312)968-4713
• Email: Kgilbert@verupharma.com
• Phone: +1(312)968-4713
• Email: Kgilbert@verupharma.com
• Phone: +1(312)968-4713
• Email: Kgilbert@verupharma.com
• Phone: +1(312)968-4713
• Email: Kgilbert@verupharma.com
• Phone: +1(312)968-4713
• Email: Kgilbert@verupharma.com
• Phone: +1(312)968-4713
• Email: Kgilbert@verupharma.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
• 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
• 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	30861783000103 [Primary]
GS1	40861783000100 [Package]; Contains: 30861783000103; Package: Case [10 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