| Primary Device ID | 03700512921677 |
| NIH Device Record Key | 78d9a087-8038-4112-9aa9-8cc74f032c69 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Irrigation/Aspiration set for RTUP/Post Operative irrigation (Urology) |
| Version Model Number | RF0501TDE2SP |
| Catalog Number | RF0501TDE2SP |
| Company DUNS | 401020409 |
| Company Name | Promepla |
| 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 | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +37797984232 |
| customer@rocamed.eu |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700512901679 [Primary] |
| GS1 | 03700512911678 [Package] Contains: 03700512901679 Package: Box 1 [15 Units] In Commercial Distribution |
| GS1 | 03700512921677 [Package] Contains: 03700512911678 Package: Box 2 [2 Units] In Commercial Distribution |
| FHF | System, Evacuator, Fluid |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-11-11 |
| Device Publish Date | 2016-09-14 |