HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI) SET400168-AD

GUDID 07290019402442

HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI). Multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment. These are the upgrade kits for Integra headframes to allow compatibility with Insightec-made PFK

INSIGHTEC LTD

Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system

• Primary Device ID: 07290019402442
• NIH Device Record Key: a9cdb5b2-c0a4-4ac5-abaf-f9e6fcbc8ced
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI)
• Version Model Number: SET400168-AD PFK TYPE 1.0 FDA/ROW INTEGRA (FMI)
• Catalog Number: SET400168-AD
• 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
• 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

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019402442 [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: 2023-07-04
• Device Publish Date: 2023-06-26

Devices Manufactured by INSIGHTEC LTD

• 07290019402442 - HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI): 2023-07-04HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI). Multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment. These are the upgrade kits for Integra headframes to allow compatibility with Insightec-made PFK
• 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
• 07290019402169 - EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE: 2023-06-22 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE w/PFK for 5 treatments for GE MR PFK package served ETO-sterile
• 07290019402176 - EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE SU: 2023-06-22 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE SU w/PFK for 1 treatment for GE MR PFK package served ETO-sterile