FDA.reportPublic FDA data

FC2

Primary DI
00861783000119
Brand
FC2
Company
Veru Inc.
Model
271594
Catalog number
271594
Device description
FC2 Female Condom
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
10861783000116PackageGS1240Not in Commercial Distribution
00861783000119PrimaryGS10
00861783000102Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086178300011610861783000116
00861783000119008617830001198617830001190861783000119
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

Contacts#

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

Regulatory Flags#

DUNS number
055300578
Device count
3
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30861783000103FC21211071211072016-09-21
00861783000126FC2 Female Condom®2001172001172021-05-11
00861783000102FC2 Female Condom®2001172001172021-05-11

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
40861783000100FC2Female Health CompanyMBU2016-09-21
10861783000116FC2Female Health CompanyMBU2016-09-21