004® ZERO ZERO FOUR® Condoms 04001

GUDID 00028373040010

Natural rubber latex condom, lubricated, thin.

OKAMOTO USA, INC.

Basic male condom, Hevea-latex
Primary Device ID00028373040010
NIH Device Record Key0eba63ce-5aea-45da-8210-1a503b74f343
Commercial Distribution Discontinuation2023-09-11
Commercial Distribution StatusNot in Commercial Distribution
Brand Name004® ZERO ZERO FOUR® Condoms
Version Model Number04001
Catalog Number04001
Company DUNS175752724
Company NameOKAMOTO USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com
Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com
Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com
Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com
Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com
Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com
Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com
Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com
Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com
Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com
Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com
Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com
Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com
Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com
Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com
Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com
Phone1-800-283-7546
EmailOkamotousa@OkamotoUSA.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100028373040010 [Primary]
GS110028373040017 [Package]
Package: Shipper [288 Units]
Discontinued: 2023-09-11
Not in Commercial Distribution

FDA Product Code

HISCondom

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-09-09
Device Publish Date2016-09-22

On-Brand Devices [004® ZERO ZERO FOUR® Condoms]

00028373040362Natural rubber latex condom, lubricated, thin
10028373040246Natural rubber latex condom, lubricated, thin.
10028373040109Natural rubber latex condom, lubricated, thin.
10028373040031Natural rubber latex condom, lubricated, thin.
00028373040010Natural rubber latex condom, lubricated, thin.

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