Ultravision2 Generator DPD-006-001

GUDID 15060417680419

The Ultravision2 System/Generator is designed to integrate surgical smoke clearing technology with the electrosurgical and ultrasonic systems that are used in electrosurgery. The UV2 Generator provides an interface between commercially available electrosurgical generators and electrosurgical instruments. The intention is to provide a system that enables the synchronization of Ionwand activation to clear the visual field with the energy output from electrosurgical or ultrasonic devices that generate the surgical smoke.

ALESI SURGICAL LIMITED

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• Primary Device ID: 15060417680419
• NIH Device Record Key: efb8ed2c-a591-4719-808d-054140861ae7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultravision2 Generator
• Version Model Number: DPD-006-001
• Catalog Number: DPD-006-001
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +442920291022
• Email: pravinpatel@alesi-surgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060417680412 [Primary]
GS1	15060417680419 [Package]; Contains: 05060417680412; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231238

FDA Product Code

• PQM: Surgical Smoke Precipitator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-21
• Device Publish Date: 2023-12-13

Devices Manufactured by ALESI SURGICAL LIMITED

• 15060417680419 - Ultravision2 Generator: 2023-12-21The Ultravision2 System/Generator is designed to integrate surgical smoke clearing technology with the electrosurgical and ultrasonic systems that are used in electrosurgery. The UV2 Generator provides an interface between commercially available electrosurgical generators and electrosurgical instruments. The intention is to provide a system that enables the synchronization of Ionwand activation to clear the visual field with the energy output from electrosurgical or ultrasonic devices that generate the surgical smoke.
• 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): 2023-12-21 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