UltravisionTM DAD-001-015

GUDID 05060417680009

UltravisionTM Visual Field Clearing System

ALESI SURGICAL LIMITED

Surgical fluid/smoke waste management system

• Primary Device ID: 05060417680009
• NIH Device Record Key: 8eae3954-aa2e-4687-92a0-019b8a21351e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltravisionTM
• Version Model Number: UltravisionTM System Starter Pack
• Catalog Number: DAD-001-015
• 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: 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	05060417680009 [Primary]

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

On-Brand Devices [UltravisionTM]

• 05060417680245: UltravisionTM Visual Field Clearing System
• 05060417680214: Ultravision Visual Field Clearing System
• 25060417680201: Ultravision Visual Field Clearing System
• 05060417680139: UltravisionTM Visual Field Clearing System
• 05060417680122: UltravisionTM Visual Field Clearing System
• 05060417680061: UltravisionTM Visual Field Clearing System
• 05060417680054: UltravisionTM Visual Field Clearing System
• 05060417680177: UltravisionTM Visual Field Clearing System
• 05060417680023: UltravisionTM Visual Field Clearing System
• 05060417680016: UltravisionTM Visual Field Clearing System
• 05060417680009: UltravisionTM Visual Field Clearing System