FDA.reportPublic FDA data

CautionWear Grande

Primary DI
00850836007472
Brand
CautionWear Grande
Company
CAUTION WEAR CORP
Model
CW0001GR
Device description
Male Latex Condom, Parallel-Sided, Smooth Texture, Large (56 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal, Single Foil Pocket, Unit of Use.
Published
2017-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012964000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K01296400056MM CONDOM,MALE NATURAL RUBBER LATEX CONDOMInnolatex Sdn. Bhd2001-11-09HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850836007489PackageGS11000In Commercial Distribution
00850836007496PackageGS14In Commercial Distribution
00850836007502PackageGS14000In Commercial Distribution
00850836007847PackageGS124In Commercial Distribution
00850836007854PackageGS150In Commercial Distribution
00850836007861PackageGS1100In Commercial Distribution
00850836007878PackageGS1200In Commercial Distribution
00850836007472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850836007489008508360074898508360074890850836007489
00850836007496008508360074968508360074960850836007496
00850836007502008508360075028508360075020850836007502
00850836007847008508360078478508360078470850836007847
00850836007854008508360078548508360078540850836007854
00850836007861008508360078618508360078610850836007861
00850836007878008508360078788508360078780850836007878
00850836007472008508360074728508360074720850836007472

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

Contacts#

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

Regulatory Flags#

DUNS number
177056145
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850836007113CautionWear L.A.Confidential - Dark DesireLAC0001DD2021-06-21
00850836007168CautionWear L.A.Confidential - Silky TouchLAC0001ST2021-06-21
00850836007762CautionWear L.A.Confidential - Dark DesireLAC0001DD2021-06-21
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

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06925634004290RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
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