| Primary Device ID | 03700512921479 |
| NIH Device Record Key | 404b2725-e1c5-49a8-8ec0-d53165f0edf1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Irrigation/Aspiration probe 16 holes, 5mmx45cm |
| Version Model Number | RF16H545 |
| Catalog Number | RF16H545 |
| Company DUNS | 401020409 |
| Company Name | Promepla |
| 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 | 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 | 00370512901471 [Primary] |
| GS1 | 03700512911470 [Package] Contains: 00370512901471 Package: Box 1 [10 Units] In Commercial Distribution |
| GS1 | 03700512921479 [Package] Contains: 03700512911470 Package: Box 2 [60 Units] In Commercial Distribution |
| GBX | Catheter, Irrigation |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2016-09-15 |