| Primary Device ID | 04013273000116 |
| NIH Device Record Key | 61d5a9bc-a299-4135-b7c9-5dddeec3fce3 |
| Commercial Distribution Discontinuation | 2023-08-16 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Active Erection System |
| Version Model Number | AES 01 |
| Company DUNS | 537500365 |
| Company Name | KESSEL medintim GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| 04013273000116 - Active Erection System | 2023-08-15Vacuum Erection Device for treatment of erectile dysfunction |
| 04013273000116 - Active Erection System | 2023-08-15 Vacuum Erection Device for treatment of erectile dysfunction |
| 04013273001557 - Vagiwell Dilator 5er Set Premium | 2023-07-28 Device to dilatate the vagina in case of Radiotherapy, Chemotherapy, after vaginal surgery, vaginismus, narrowness of the vagina |
| 04013273001564 - Vaginal Dilator 3er Set small | 2023-07-28 Device to dilatate the vagina in case of Radiotherapy, Chemotherapy, after vaginal surgery, vaginismus, narrowness of the vagina |
| 04013273001571 - Vaginal Dilator 3er Set large | 2023-07-28 Device to dilatate the vagina in case of Radiotherapy, Chemotherapy, after vaginal surgery, vaginismus, narrowness of the vagina |
| 04013273000208 - Constriction Ring 9mm | 2022-08-04 Constriction ring or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction |
| 04013273000215 - Constriction Ring 12mm | 2022-08-04 Constriction ring in 12mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction |
| 04013273000222 - Constriction Ring 15mm | 2022-08-04 Constriction ring in 15mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction |
| 04013273000239 - Constriction Ring 18mm | 2022-08-04 Constriction ring in 18mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction |