FINESSE FIN2-220

GUDID H671FIN22200

Electrosurgical Generator with Integrated Smoke Evacuation System, 230 VAC

UTAH MEDICAL PRODUCTS, INC.

Electrosurgical system generator

• Primary Device ID: H671FIN22200
• NIH Device Record Key: 8d8c914e-1591-4f8c-8a27-d04d1344729a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FINESSE
• Version Model Number: Finesse II+, 230VAC
• Catalog Number: FIN2-220
• Company DUNS: 094651270
• Company Name: UTAH MEDICAL PRODUCTS, INC.
• 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: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H671FIN22200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123310

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2016-09-23

On-Brand Devices [FINESSE]

• H671FIN8000: Starter Kit, Including 1 ea. DLS-200, 5 ea. ESU-305, 1 ea. ESU-501, 15 ea. ESU-502, & 10 ea. ES-
• H671FIN22200: Electrosurgical Generator with Integrated Smoke Evacuation System, 230 VAC
• H671FIN2200: Electrosurgical Generator with Integrated Smoke Evacuation System, 230 VAC
• H671FIN21100: Electrosurgical Generator with Integrated Smoke Evacuation System, 115 VAC
• H671FIN1100: Electrosurgical Generator with Integrated Smoke Evacuation System, 115 VAC