UltravsionTM DSD-001-034

GUDID 05060417680047

UltravisionTM Visual Field Clearing System

ALESI SURGICAL LIMITED

Surgical fluid/smoke waste management system

• Primary Device ID: 05060417680047
• NIH Device Record Key: 79b4ee1d-72b3-4aaf-bc5f-d2f701b7f76c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltravsionTM
• Version Model Number: Ultravision Battery (x2)
• Catalog Number: DSD-001-034
• Company DUNS: 219516254
• Company Name: ALESI SURGICAL LIMITED
• Device Count: 2
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060417680047 [Primary]
GS1	05060417680252 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN150022

FDA Product Code

• PQM: Surgical Smoke Precipitator

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-12

Devices Manufactured by ALESI SURGICAL LIMITED

• 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