| Primary Device ID | 10028373050030 |
| NIH Device Record Key | 8914a5c8-baf6-4fbd-8f7a-0581865fa16e |
| Commercial Distribution Discontinuation | 2023-09-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | 004® ZERO ZERO FOUR® Aloe Condoms |
| Version Model Number | 05003 |
| Catalog Number | 05003 |
| Company DUNS | 175752724 |
| Company Name | OKAMOTO USA, INC. |
| Device Count | 3 |
| 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 | 00028373050033 [Primary] |
| GS1 | 10028373050030 [Package] Contains: 00028373050033 Package: Shipper [192 Units] Discontinued: 2023-09-11 Not in Commercial Distribution |
| GS1 | 80028373050039 [Unit of Use] |
| 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 |
| 10028373050245 | Natural rubber latex condom, lubricated with aloe extract, thin. |
| 10028373050108 | Natural rubber latex condom, lubricated with aloe extract, thin. |
| 10028373050030 | Natural rubber latex condom, lubricated with aloe extract, thin. |