FDA.reportPublic FDA data

PRUDENCE SENSITIVE C/12

Primary DI
00812420030211
Brand
PRUDENCE SENSITIVE C/12
Company
DKT de México, S.A. de C.V.
Model
Condom
Device description
Contraceptive, condom, male Basic male condom, Hevea-latex A 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.
Published
2020-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HISCondom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812420030211PackageGS112In Commercial Distribution
10812420030218PackageGS16In Commercial Distribution
20812420030215PackageGS124In Commercial Distribution
10812420030096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812420030211008124200302118124200302110812420030211
1081242003021810812420030218
2081242003021520812420030215
1081242003009610812420030096

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
814851960
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10812420030072PRUDENCE CLASSIC C/12Condom 2020-02-14
10812420030096PRUDENCE SENSITIVE C/12Condom 2020-02-14
00812420030228PRUDENCE CLASSIC C/12Condom 2020-02-14
00812420030242PRUDENCE MIX C/3Condom 2020-02-14
00812420030181PRUDENCE BANANACondom 2020-01-21
00812420030259PRUDENCE MIX C/12Condom 2020-01-21
10812420030188PRUDENCE BANANACondom 2020-01-21
20812420030185PRUDENCE BANANACondom 2020-01-21
10812420030010Prudence MintCondom 2018-06-20
20812420030024Prudence ChocolateCondom 2018-06-20
20812420030000Prudence StrawberryCondom 2018-06-20
20812420030017Prudence MintCondom 2018-06-20
20812420030031Prudence ClassicCondom 2018-06-20
20812420030048Prudence SensitiveCondom 2018-06-20
10812420030003Prudence StrawberryCondom 2018-06-20
10812420030027Prudence ChocolateCondom 2018-06-20
10812420030034Prudence ClassicCondom 2018-06-20
10812420030041Prudence SensitiveCondom 2018-06-20
00812420030006Prudence StrawberryCondom 2018-06-20
00812420030013Prudence MintCondom 2018-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977708239688ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239695ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239701ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239718ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239725ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239732ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
00860014891533HUNKHunk World, Inc.HIS2026-08-19
00860014891540HUNKHunk World, Inc.HIS2026-08-19
00860014891557HUNKHunk World, Inc.HIS2026-08-19
08852961028959Lelo Hex Lubricated Natural Rubber Latex Condom 36’sLeloi ABHIS2026-07-27
08852961028935Lelo Hex Lubricated Natural Rubber Latex Condom collection 3 packLeloi ABHIS2026-07-22
08852961028942Lelo Hex Lubricated Natural Rubber Latex Condom collection 12 packLeloi ABHIS2026-07-22
06936296747371Male Latex CondomsShanghai Personage Hygiene Products Co.,Ltd.HIS2026-06-26
08852961033205Lelo Hex Lubricated Natural Rubber Latex Condom collection 3 packLeloi ABHIS2026-06-25
08852961033212Lelo Hex Lubricated Natural Rubber Latex Condom collection 12 packLeloi ABHIS2026-06-25
08859798108960LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-06-25
08859798108977LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-06-25
06925634004245RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004252RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004269RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004276RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004283RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004290RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
00726893120365One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120730One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120747One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120778One Unity CollectionGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120945One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120952One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120969One LuxGLOBAL PROTECTION CORP.HIS2026-06-08