004® ZERO ZERO FOUR® Aloe Condoms 05003

GUDID 10028373050030

Natural rubber latex condom, lubricated with aloe extract, thin.

OKAMOTO USA, INC.

Basic male condom, Hevea-latex
Primary Device ID10028373050030
NIH Device Record Key8914a5c8-baf6-4fbd-8f7a-0581865fa16e
Commercial Distribution Discontinuation2023-09-11
Commercial Distribution StatusNot in Commercial Distribution
Brand Name004® ZERO ZERO FOUR® Aloe Condoms
Version Model Number05003
Catalog Number05003
Company DUNS175752724
Company NameOKAMOTO USA, INC.
Device Count3
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
GS100028373050033 [Primary]
GS110028373050030 [Package]
Contains: 00028373050033
Package: Shipper [192 Units]
Discontinued: 2023-09-11
Not in Commercial Distribution
GS180028373050039 [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 Number3
Public Version Date2024-09-09
Device Publish Date2016-09-22

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

10028373050245Natural rubber latex condom, lubricated with aloe extract, thin.
10028373050108Natural rubber latex condom, lubricated with aloe extract, thin.
10028373050030Natural rubber latex condom, lubricated with aloe extract, thin.

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