FDA.reportPublic FDA data

004® ZERO ZERO FOUR® Condoms

Primary DI
10028373040031
Brand
004® ZERO ZERO FOUR® Condoms
Company
OKAMOTO USA, INC.
Model
04003
Catalog number
04003
Device description
Natural rubber latex condom, lubricated, thin.
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10028373040031PackageGS1192Not in Commercial Distribution
00028373040034PrimaryGS10
80028373040030Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002837304003110028373040031
00028373040034000283730400340283730400340028373040034
8002837304003080028373040030

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

Contacts#

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

Regulatory Flags#

DUNS number
175752724
Device count
3
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
false
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
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
00028373050101004® ZERO ZERO FOUR® Aloe Condoms05010050102016-09-22
00028373050248004® ZERO ZERO FOUR® Aloe Condoms05024050242016-09-22
00028373410127BEYOND SEVEN ® ALOE ENRICHED Condoms41012410122016-09-22
00028373040010004® ZERO ZERO FOUR® Condoms04001040012016-09-22
10028373040109004® ZERO ZERO FOUR® Condoms04010040102016-09-22

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06925634004283RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
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