Exablate Neuro Treatment Accessories Kit SET004307-ROW

GUDID 07290019402565

Exablate Neuro Treatment Accessories Kit

INSIGHTEC LTD

Ultrasonic hyperthermia system

• Primary Device ID: 07290019402565
• NIH Device Record Key: d63dffdb-2044-4114-87db-d300c06f1144
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exablate Neuro Treatment Accessories Kit
• Version Model Number: Exablate 4000
• Catalog Number: SET004307-ROW
• Company DUNS: 532169513
• Company Name: INSIGHTEC LTD
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019402565 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150038

FDA Product Code

• POH: Mr-Guided Focused Ultrasound System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-09
• Device Publish Date: 2025-05-01

Devices Manufactured by INSIGHTEC LTD

• 07290019402565 - Exablate Neuro Treatment Accessories Kit: 2025-05-09Exablate Neuro Treatment Accessories Kit
• 07290019402565 - Exablate Neuro Treatment Accessories Kit: 2025-05-09 Exablate Neuro Treatment Accessories Kit
• 07290019402558 - 7290019402558: 2025-01-09 Transcranial, magnetic resonance, image-guided focused ultrasound (MRgFUS) system that is designed for Incisionless ablation of
• 07290019402442 - HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI): 2023-07-04 HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI). Multi use Stereotactic Frame Set for fixing the skull position during neuro FUS cl
• 07290019402466 - HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI): 2023-07-04 HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI). Multi use Stereotactic Frame Set for fixing the skull position during neuro FUS cl
• 07290019402121 - EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI: 2023-06-22 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI w/PFK for 5 treatments for Siemens MR PFK package served ETO-sterile
• 07290019402138 - EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI SU: 2023-06-22 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI w/PFK for 1 treatment for Siemens MR PFK package served ETO-sterile
• 07290019402145 - EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE: 2023-06-22 EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE w/PFK for 5 treatments for GE MR PFK package served ETO-sterile
• 07290019402152 - EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI SU: 2023-06-22 EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE SU w/PFK for 1 treatment for GE MR PFK package served ETO-sterile