| Primary Device ID | 03700512986294 |
| NIH Device Record Key | afc2be82-749d-4d9c-8a4a-10680da36046 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nitinol Stone Extractor, TIPLESS basket 4 wires, 1.9 Fr Mini |
| Version Model Number | 09-0025 |
| Catalog Number | ROSZ1920ST |
| 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 | |
| Phone | +37797984232 |
| customer@rocamed.eu | |
| Phone | +37797984232 |
| customer@rocamed.eu | |
| Phone | +37797984232 |
| customer@rocamed.eu | |
| Phone | +37797984232 |
| customer@rocamed.eu | |
| Phone | +37797984232 |
| customer@rocamed.eu | |
| Phone | +37797984232 |
| customer@rocamed.eu | |
| Phone | +37797984232 |
| customer@rocamed.eu | |
| Phone | +37797984232 |
| customer@rocamed.eu | |
| Phone | +37797984232 |
| customer@rocamed.eu |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700512966296 [Primary] |
| GS1 | 03700512976295 [Package] Contains: 03700512966296 Package: Box [1 Units] In Commercial Distribution |
| GS1 | 03700512986294 [Package] Contains: 03700512976295 Package: Box [4 Units] In Commercial Distribution |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2017-11-09 |