EXABLATE EXABLATE 2000

GUDID 07290015461009

System for non-invasive tumor ablation through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS).

INSIGHTEC LTD

Therapeutic oncological/gynaecological ultrasound system

• Primary Device ID: 07290015461009
• NIH Device Record Key: 8c976c29-8b55-4122-bb0e-2f1ddd3ad0fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXABLATE
• Version Model Number: 2000
• Catalog Number: EXABLATE 2000
• Company DUNS: 532169513
• Company Name: INSIGHTEC LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 18663922528
• Email: info@insightec.com

Device Dimensions

• Weight: 890 Kilogram

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015461009 [Primary]

FDA Product Code

• LSY: Ultrasound,Hyperthermia, Cancer Treatment

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-08-03

On-Brand Devices [EXABLATE]

• 07290015461016: System for non-invasive tumor ablation through Focal Ultrasound (FUS) treatment under Magnetic R
• 07290015461009: System for non-invasive tumor ablation through Focal Ultrasound (FUS) treatment under Magnetic R