ExAblate 2100/2100V1/2100V1-AR UPPER PELVIC COIL ASM000426-AA

GUDID 07290015461504

ExAblate 2100/2100V1/2100V1-AR UPPER PELVIC COIL for MRI imaging during Body FUS treatments. Contains Upper and Lower part:

INSIGHTEC LTD

Therapeutic oncological/gynaecological ultrasound system

• Primary Device ID: 07290015461504
• NIH Device Record Key: 981eb018-8c2f-40ad-aae3-b97b149cd45c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExAblate 2100/2100V1/2100V1-AR UPPER PELVIC COIL
• Version Model Number: ASM000426-AA ExAblate 2100/2100V1/2100V1-AR UPPER
• Catalog Number: ASM000426-AA
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015461504 [Primary]

FDA Product Code

• NRZ: Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

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: 2019-11-08
• Device Publish Date: 2018-11-29

Devices Manufactured by INSIGHTEC LTD

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• 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
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• 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