| Primary Device ID | 04059082009339 |
| NIH Device Record Key | 4c26a4e9-6a80-438c-8af2-001f7bd4235e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Urethrotomy knife |
| Version Model Number | 195 120 001BC |
| Company DUNS | 507185952 |
| Company Name | SOPRO-COMEG GmbH |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04059082009339 [Primary] |
| EZO | Urethrotome |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04059082009339]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-12 |
| 04059082031095 | 195 400 110 |
| 04059082029900 | 397 500 038 |
| 04059082029894 | 397 500 037 |
| 04059082029849 | 195 810 123 |
| 04059082029832 | 195 810 122 |
| 04059082029825 | 195 810 121 |
| 04059082029801 | 195 120 020 |
| 04059082029795 | 195 120 001 |
| 04059082027333 | 397 500 038BC |
| 04059082027326 | 397 500 037BC |
| 04059082009889 | 195 810 123BC |
| 04059082009872 | 195 810 122BC |
| 04059082009865 | 195 810 121BC |
| 04059082009582 | 195 400 110 C |
| 04059082009346 | 195 120 020BC |
| 04059082009339 | 195 120 001BC |