Sulis

GUDID H787806011US0

LCS Unit

ANGIODYNAMICS UK LIMITED

Microwave hyperthermia system

• Primary Device ID: H787806011US0
• NIH Device Record Key: 9252ed78-6421-45ce-bcca-06fff4cf013d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sulis
• Version Model Number: 806-011
• Company DUNS: 211086221
• Company Name: ANGIODYNAMICS UK 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: 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: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H787806011US0 [Primary]

FDA Product Code

• NEY: SYSTEM, ABLATION, MICROWAVE AND 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-21

On-Brand Devices [Sulis]

• H787806011US0: LCS Unit
• H787806010US0: SulisVpMTA Generator