Primary Device ID | 00028373040010 |
NIH Device Record Key | 0eba63ce-5aea-45da-8210-1a503b74f343 |
Commercial Distribution Discontinuation | 2023-09-11 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | 004® ZERO ZERO FOUR® Condoms |
Version Model Number | 04001 |
Catalog Number | 04001 |
Company DUNS | 175752724 |
Company Name | OKAMOTO USA, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com | |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com | |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com | |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com | |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com | |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com | |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com | |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com | |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com | |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com | |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com | |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com | |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com | |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com | |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com | |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com | |
Phone | 1-800-283-7546 |
Okamotousa@OkamotoUSA.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00028373040010 [Primary] |
GS1 | 10028373040017 [Package] Package: Shipper [288 Units] Discontinued: 2023-09-11 Not in Commercial Distribution |
HIS | Condom |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2024-09-09 |
Device Publish Date | 2016-09-22 |
00028373040362 | Natural rubber latex condom, lubricated, thin |
10028373040246 | Natural rubber latex condom, lubricated, thin. |
10028373040109 | Natural rubber latex condom, lubricated, thin. |
10028373040031 | Natural rubber latex condom, lubricated, thin. |
00028373040010 | Natural rubber latex condom, lubricated, thin. |