FC2

Primary DI
40861783000100
Brand
FC2
Company
Female Health Company
Model
121107
Catalog number
121107
Device description
FC2 Female Condom
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBUCondom, female, single-use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBUSingle-Use Internal CondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P080002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P080002000FC2 FEMALE CONDOMClear Future, Inc.2009-03-10MBU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40861783000100PackageGS110In Commercial Distribution
30861783000103PrimaryGS10
00000000000000Unit of UseGS10
00861783000102Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4086178300010040861783000100
3086178300010330861783000103
00000000000000000000000000000000000000000000000000000
00861783000102008617830001028617830001020861783000102

GMDN Terms#

Term, Definition table
TermDefinition
Female condom, synthetic polymerA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length170Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place away from direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(312)595-9123bannonson@femalehealthcompany.
+1(312)595-9123bannonson@femalehealthcompany.com
312-968-4713Kgilbert@verupharma.com
+1(312)968-4713Kgilbert@verupharma.com

Regulatory Flags#

DUNS number
055300578
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10861783000116FC22715942715942016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893115804One and FC2GLOBAL PROTECTION CORP.MBU2023-12-04
80726893115800One and FC2GLOBAL PROTECTION CORP.MBU2023-12-04
00861783000126FC2 Female Condom®Veru Inc.MBU2021-05-11
00861783000102FC2 Female Condom®Veru Inc.MBU2021-05-11
30861783000103FC2Veru Inc.MBU2016-09-21
00861783000119FC2Veru Inc.MBU2016-09-21
10861783000116FC2Female Health CompanyMBU2016-09-21