| Primary Device ID | 35060417680468 |
| NIH Device Record Key | 592948f7-028f-41bf-be33-306addfade2b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ultravision2 Integrated Monopolar L Hook (H/S) |
| Version Model Number | DPD-006-201 |
| Catalog Number | DPD-006-201 |
| Company DUNS | 219516254 |
| Company Name | ALESI SURGICAL LIMITED |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com | |
| Phone | +4402920291022 |
| pravinpatel@alesi-surgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060417680467 [Primary] |
| GS1 | 15060417680464 [Package] Package: Inner Carton [5 Units] In Commercial Distribution |
| GS1 | 25060417680461 [Package] Contains: 15060417680464 Package: Shipper Box [4 Units] In Commercial Distribution |
| GS1 | 35060417680468 [Package] Contains: 05060417680467 Package: Carton [1 Units] In Commercial Distribution |
| PQM | Surgical Smoke Precipitator |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-21 |
| Device Publish Date | 2023-12-13 |
| 15060417680419 - Ultravision2 Generator | 2023-12-21 The Ultravision2 System/Generator is designed to integrate surgical smoke clearing technology with the electrosurgical and ultra |
| 35060417680468 - Ultravision2 Integrated Monopolar L Hook (H/S) | 2023-12-21The Integrated Monopolar L-Hook (H/S)™ is a bifunctional device that combines proprietary visual field clearing and monopolar HF tissue and coagulation in a single device. The Integrated Monopolar L-Hook (H/S)™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The Integrated Monopolar L-Hook (H/S)™ provides two recessed smoke clearing emitters that are automatically activated to clear the visual field when the device cutting function (HF) is activated. The mode of action of visual field clearing is electrostatic precipitation as per the predicate Ultravision system. When the tissue cutting is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision 2 generator user interface. Activation of the HF function of the Integrated Monopolar L-Hook (H/S)™ is via a yellow (Cut) or blue (Coag) button located on the handpiece, or via a footswitch if this connected to the parent electrosurgical generator which is connected to the Ultravision 2 system. The Integrated Monopolar L-Hook (H/S)™ itself is incompatible with the connectors of third party electrosurgical generators. On demand visual field clearing only can also be applied by activation of a third grey button on the handle. This clearing field action is stopped immediately after release of the grey button. |
| 35060417680468 - Ultravision2 Integrated Monopolar L Hook (H/S) | 2023-12-21 The Integrated Monopolar L-Hook (H/S)™ is a bifunctional device that combines proprietary visual field clearing and monopolar |
| 05060417680245 - UltravisionTM | 2018-12-31 UltravisionTM Visual Field Clearing System |
| 05060417680009 - UltravisionTM | 2018-07-06 UltravisionTM Visual Field Clearing System |
| 05060417680016 - UltravisionTM | 2018-07-06 UltravisionTM Visual Field Clearing System |
| 05060417680023 - UltravisionTM | 2018-07-06 UltravisionTM Visual Field Clearing System |
| 05060417680177 - UltravisionTM | 2018-07-06 UltravisionTM Visual Field Clearing System |
| 05060417680047 - UltravsionTM | 2018-07-06 UltravisionTM Visual Field Clearing System |