Ultravision2 IonPencil DPD-007-001

GUDID 15060417680495

The Ultravision2 IonPencil™ is a bifunctional open surgery device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device. It’s addition to the Ultravision2 System adds the general open procedure capability to the Ultravision2™ indications of use along with the new single use accessory.

ALESI SURGICAL LIMITED

Surgical plume evacuation system

• Primary Device ID: 15060417680495
• NIH Device Record Key: 08c83974-0b88-4235-a552-efd371de9475
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultravision2 IonPencil
• Version Model Number: DPD-007-001
• Catalog Number: DPD-007-001
• 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: 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

Customer Support Contacts

• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com
• Phone: +4402920291022
• Email: pravinpatel@alesi-surgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060417680498 [Primary]
GS1	15060417680495 [Package]; Contains: 05060417680498; Package: Carton [40 Units]; In Commercial Distribution
GS1	25060417680492 [Package]; Package: Shipper Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240868

FDA Product Code

• PQM: Surgical Smoke Precipitator

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-28
• Device Publish Date: 2024-08-20

Devices Manufactured by ALESI SURGICAL LIMITED

• 15060417680495 - Ultravision2 IonPencil: 2024-08-28The Ultravision2 IonPencil™ is a bifunctional open surgery device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device. It’s addition to the Ultravision2 System adds the general open procedure capability to the Ultravision2™ indications of use along with the new single use accessory.
• 15060417680495 - Ultravision2 IonPencil: 2024-08-28 The Ultravision2 IonPencil™ is a bifunctional open surgery device that combines proprietary smoke management (via visual field
• 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