One and FC2

Primary DI
80726893115800
Brand
One and FC2
Company
GLOBAL PROTECTION CORP.
Model
110100U-F
Device description
FC2@Home Mailer w/Move 7 Internal Condoms, 5 Move Sachets
Published
2023-12-04
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
MBUSingle-Use Internal Condom

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00726893115804PrimaryGS10
80726893115800Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00726893115804007268931158047268931158040726893115804
8072689311580080726893115800

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a dark, dry place. Avoid excessive heat.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6179462800ccataldo@globalprotection.com

Regulatory Flags#

DUNS number
364614362
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
false
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
00726893120587Harmony non-Latex DamPHA101R2026-06-04
00726893120754TrustexTXD05U2026-06-04
00726893120761Super sensitiveCRDF-62026-06-04
20726893120482Mixed Pleasure110109C2026-06-04
20726893120710Glowing Pleasures11500BC2026-06-04
20726893120574One Super sensitive11600CY2026-04-28
20726893120673One Classic Select11000BYC2026-04-28
20726893120680One Classic Select11000BC2026-04-28
20726893120697One Flavorwaves110200BC2026-04-28
20726893120703One Legend11400BC2026-04-28
20726893120468One Ultra Feel112309C2026-04-24
20726893120475One Flex1131009C2026-04-24
20726893120499One Super Studs111709C2026-04-24
20726893120505One Vanish111309C2026-04-24
20726893120512One Pleasure Plus110309C2026-04-24
20726893120529One Super Sensitive11609C2026-04-24
20726893120536ONE Flavorwaves110209C2026-04-24
20726893120543One Legend11409C2026-04-24
20726893120550One Tattoo Touch112009C2026-04-24
20726893120567One Glowing Pleasures11509C2026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893115804One 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
40861783000100FC2Female Health CompanyMBU2016-09-21
10861783000116FC2Female Health CompanyMBU2016-09-21