UltravisionTM DAD-001-003

GUDID 25060417680201

Ultravision Visual Field Clearing System

ALESI SURGICAL LIMITED

Surgical fluid/smoke waste management system

• Primary Device ID: 25060417680201
• NIH Device Record Key: 83ee661d-1e79-45a1-8375-853e4e7ff888
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltravisionTM
• Version Model Number: IonwandTM Sterile Pack
• Catalog Number: DAD-001-003
• 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: true
• 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	05060417680207 [Primary]
GS1	15060417680204 [Package]; Contains: 05060417680207; Package: [10 Units]; In Commercial Distribution
GS1	25060417680201 [Package]; Contains: 15060417680204; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN150022

FDA Product Code

• PQM: Surgical Smoke Precipitator

Sterilization

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

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