| Primary Device ID | 03700512975236 |
| NIH Device Record Key | 22a1c38e-6bb8-4a6b-b634-417a71b6f7eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XenX – Stone Management Device (7 cm tip Proximal Stone) |
| Version Model Number | ROXE03807ST |
| Catalog Number | ROXE03807ST |
| 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 | |
| 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 | 03700512965237 [Primary] |
| GS1 | 03700512975236 [Package] Contains: 03700512965237 Package: Box label [1 Units] In Commercial Distribution |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2016-10-11 |