| Primary Device ID | 03700512986256 |
| NIH Device Record Key | 9522ea2c-8a6b-4741-8cd5-2bf1db6fd7c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nitinol Stone Extractor, helical basket, 4 wires, 2.5 Fr |
| Version Model Number | 09-0021 |
| Catalog Number | ROSH2500ST |
| 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 | 03700512966258 [Primary] |
| GS1 | 03700512976257 [Package] Contains: 03700512966258 Package: Box [1 Units] In Commercial Distribution |
| GS1 | 03700512986256 [Package] Contains: 03700512976257 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 |