FDA.report

double one

Primary DI
06901691564656
Brand
double one
Company
Guangzhou Double One Latex Products Co., Ltd
Model
53MM Standard
Published
2018-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HISCondom

Product Code Classifications

CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06901691564656PrimaryGS10
36901691564657Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06901691564656069016915646566901691564656
3690169156465736901691564657

GMDN Terms

TermDefinition
Basic male condom, Hevea-latexA Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
560081917
Device count
36
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
true
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
80028373140105WINK CLOSEROKAMOTO USA, INC.HIS2026-03-11
80028373149993WINK CLOSEROKAMOTO USA, INC.HIS2026-03-06
06925634004177AowawoSuzhou Colourway New Material Co., Ltd.HIS2026-03-02
06925634004214AowawoSuzhou Colourway New Material Co., Ltd.HIS2026-03-02
06925634004221AowawoSuzhou Colourway New Material Co., Ltd.HIS2026-03-02
06925634004238AowawoSuzhou Colourway New Material Co., Ltd.HIS2026-03-02
80860014891508HUNKGLOBAL PROTECTION CORP.HIS2026-02-23
80860014891515Hunk WorldGLOBAL PROTECTION CORP.HIS2026-02-23
00860015047229Condom SenseGLOBAL PROTECTION CORP.HIS2026-02-23
10860015047233Condom senseGLOBAL PROTECTION CORP.HIS2026-02-23
04897041441680Smile Makers Come ConnectedRamblin Brands USA LLCHIS2026-02-13
18859798108073LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
18859798108080LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
00860014772207DOGTAG CONDOMSSuzhou Colourway New Material Co., Ltd.HIS2025-12-17
00860014772214DOGTAG CONDOMSSuzhou Colourway New Material Co., Ltd.HIS2025-12-17
09556807501949XO!RICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-15
18859798107878LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-12-03
09556807500850GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
09556807500874GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
09556807500898GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
06977708230012ZIOXX Natural Rubber Latex Male CondomShaoguan Regenex Pharmaceutical Co., Ltd.HIS2025-11-24
06977708230029ZIOXX Natural Rubber Latex Male CondomShaoguan Regenex Pharmaceutical Co., Ltd.HIS2025-11-24
06977708230036ZIOXX Natural Rubber Latex Male CondomShaoguan Regenex Pharmaceutical Co., Ltd.HIS2025-11-24
06977708230043ZIOXX Natural Rubber Latex Male CondomShaoguan Regenex Pharmaceutical Co., Ltd.HIS2025-11-24
00813356005014Crown Lubricated 500 ct BagPARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONHIS2025-11-11
00813356005069Crown Lubricated 250 ct BagPARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONHIS2025-11-11
00813356005137Kimono Bowl Microthin 40 ct BowlPARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONHIS2025-11-11
00813356005205Crown Lubricated 100 ct BagPARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONHIS2025-11-11
00813356005380Paradise Super Thin 100 CondomPARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONHIS2025-09-05
18859798107267LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04