004® ZERO ZERO FOUR® CONDOMS 04036

GUDID 00028373040362

Natural rubber latex condom, lubricated, thin

OKAMOTO USA, INC.

Basic male condom, Hevea-latex
Primary Device ID00028373040362
NIH Device Record Key97d3d6a5-46c3-4f75-bd7d-21453c48916b
Commercial Distribution Discontinuation2023-09-11
Commercial Distribution StatusNot in Commercial Distribution
Brand Name004® ZERO ZERO FOUR® CONDOMS
Version Model Number04036
Catalog Number04036
Company DUNS175752724
Company NameOKAMOTO USA, INC.
Device Count36
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
GS100028373040362 [Primary]
GS110028373040369 [Package]
Package: Shipper [24 Units]
Discontinued: 2023-09-11
Not in Commercial Distribution
GS180028373040368 [Unit of Use]

FDA Product Code

HISCondom

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-09-09
Device Publish Date2018-12-07

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.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.