ExAblate 2100V1 LOWER PELVIC COIL ASSEMBLY ARTIST 1.5T ASC001361-AR

GUDID 07290015461467

ExAblate 2100V1 LOWER PELVIC COIL for 1.5T GE ARTIST MR guided FUS Body (uterine fibroids, bone mets) treatments

INSIGHTEC LTD

Therapeutic oncological/gynaecological ultrasound system

• Primary Device ID: 07290015461467
• NIH Device Record Key: cd53b69c-ea57-444a-9c74-0fd74b2c45bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExAblate 2100V1 LOWER PELVIC COIL ASSEMBLY ARTIST 1.5T
• Version Model Number: ASC001361-AR ExAblate 2100V1 LOWER PELVIC COIL ASS
• Catalog Number: ASC001361-AR
• 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	07290015461467 [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

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