FDA.reportPublic FDA data

CautionWear L.A.Confidential - Dark Desire

Primary DI
00850836007762
Brand
CautionWear L.A.Confidential - Dark Desire
Company
CAUTION WEAR CORP
Model
LAC0001DD
Device description
Male Latex Condom, Contoured, Regular Fit (53 mm), Parallel-Sided, N-9 FREE, Transparent in Color (clear latex), With Reservoir Tip, Lubricated With Ultra-Smooth Silicon-Based Lubricant
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
00850836007762PackageGS124In Commercial Distribution
00850836007779PackageGS150In Commercial Distribution
00850836007786PackageGS1100In Commercial Distribution
00850836007793PackageGS1200In Commercial Distribution
00850836007113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850836007762008508360077628508360077620850836007762
00850836007779008508360077798508360077790850836007779
00850836007786008508360077868508360077860850836007786
00850836007793008508360077938508360077930850836007793
00850836007113008508360071138508360071130850836007113

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature32 Degrees Celsius100 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
603-598-8500anatoli@cautionwearcorp.com

Regulatory Flags#

DUNS number
177056145
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
00850836007472CautionWear GrandeCW0001GR2017-10-11
00850836007113CautionWear L.A.Confidential - Dark DesireLAC0001DD2021-06-21
00850836007168CautionWear L.A.Confidential - Silky TouchLAC0001ST2021-06-21
00850836007724CautionWear L.A.Confidential - Silky TouchLAC0001ST2021-06-21
00850836007069CautionWear L.A.Confidential - Secret PassionLAC0001SP2021-06-18
00850836007397CautionWear PPECW0001PPE2017-02-20
00850836007014L.A.Confidential - Love TriangleLAC0001LT2017-10-11
00850836007212CautionWear Iron GripCW0001IG2016-09-03
00850836007298CautionWear Wild RoseCW0001WR2016-10-10
00850836007335FPACU0001FPA2016-10-10
00850836007359CautionWear Black IceCW0001BI2017-02-21
00850836007250CautionWear ClassicCW0001CL2016-09-02
00850836007328CautionWear Wild RoseCW0001WR2016-10-10
00850836007342FPACU0001FPA2016-10-10
00850836007373CautionWear Black IceCW0001BI2017-02-21
00850836007410CautionWear PPECW0001PPE2017-02-20
00850836007502CautionWear GrandeCW0001GR2017-10-11
00850836007434CautionWear Mission-707CW0001M7072017-02-23
00850836007458CautionWear Mission-707CW0001M7072017-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00726893120778One Unity CollectionGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120945One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
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00726893120969One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
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00726893120761Super sensitiveGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120482Mixed PleasureGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120710Glowing PleasuresGLOBAL PROTECTION CORP.HIS2026-06-04
00860013783549CaliberCaliber Brand LLCHIS2026-06-02
00860013783556CaliberCaliber Brand LLCHIS2026-06-02
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-27
08859798108076LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
08859798108083LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
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