FC2 Female Condom®

Primary DI
00861783000102
Brand
FC2 Female Condom®
Company
Veru Inc.
Model
200117
Catalog number
200117
Device description
FC2 Female Condom®
Published
2021-05-11
Public version status
New
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
10861783000123PackageGS16In Commercial Distribution
00861783000126PrimaryGS10
00861783000102Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086178300012310861783000123
00861783000126008617830001268617830001260861783000126
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
312-968-4713Kgilbert@verupharma.com
+1(312)968-4713Kgilbert@verupharma.com

Regulatory Flags#

DUNS number
055300578
Device count
12
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
00861783000119FC22715942715942016-09-21
30861783000103FC21211071211072016-09-21
00861783000126FC2 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
30861783000103FC2Veru Inc.MBU2016-09-21
00861783000119FC2Veru Inc.MBU2016-09-21
40861783000100FC2Female Health CompanyMBU2016-09-21
10861783000116FC2Female Health CompanyMBU2016-09-21