FDA.reportPublic FDA data

004® ZERO ZERO FOUR® Aloe Condoms

Primary DI
00028373050101
Brand
004® ZERO ZERO FOUR® Aloe Condoms
Company
OKAMOTO USA, INC.
Model
05010
Catalog number
05010
Device description
Natural rubber latex condom, lubricated with aloe extract, thin.
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
10028373050108PackageGS148Not in Commercial Distribution
00028373050101PrimaryGS10
80028373050107Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002837305010810028373050108
00028373050101000283730501010283730501010028373050101
8002837305010780028373050107

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.

Contacts#

Phone, Email table
PhoneEmail
1-800-283-7546Okamotousa@OkamotoUSA.com

Regulatory Flags#

DUNS number
175752724
Device count
10
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00028373140116WINK CLOSER140112026-03-11
80028373140105WINK CLOSER140112026-03-11
00028373149997WINK CLOSER149992026-03-06
80028373149993WINK CLOSER149992026-03-06
00028373749104Beyond BodiHeat®749102020-08-26
00028373749821Beyond BodiHeat®749822020-08-26
00028373749838Beyond BodiHeat®749832020-08-26
00028373749845Beyond BodiHeat®749842020-08-26
00028373749883Beyond BodiHeat®749882020-08-26
00028373149980WINK CLOSER149982024-09-06
80028373149986WINK CLOSER149982024-09-06
00028373040034004® ZERO ZERO FOUR® Condoms04003040032016-09-22
00028373040102004® ZERO ZERO FOUR® Condoms04010040102016-09-22
00028373040249004® ZERO ZERO FOUR® Condoms04024040242016-09-22
00028373050033004® ZERO ZERO FOUR® Aloe Condoms05003050032016-09-22
00028373050248004® ZERO ZERO FOUR® Aloe Condoms05024050242016-09-22
00028373410127BEYOND SEVEN ® ALOE ENRICHED Condoms41012410122016-09-22
00028373040010004® ZERO ZERO FOUR® Condoms04001040012016-09-22
10028373040031004® ZERO ZERO FOUR® Condoms04003040032016-09-22
10028373040109004® ZERO ZERO FOUR® Condoms04010040102016-09-22

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