Neuro V2 Kit 3T for USA SET000960-AA

GUDID 07290015461429

Kit for single use during a Neuro V2 treatment guided under 3T MRI guidance. Kit content: Part Description ASM000355 PATIENT MEMBRANE PACKING ASSY SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET SET000961 EXABLATE NEURO CLEANING KIT SET400189-AA NEURO TREATMENT ACCESSORIES KIT

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: 07290015461429
• NIH Device Record Key: 3d227057-b4a6-4188-bebd-ceaaa89ed9a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuro V2 Kit 3T for USA
• Version Model Number: SET000960-AA Neuro V2 Kit 3T for USA
• Catalog Number: SET000960-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: true
• Device Combination Product: false
• Single Use: true
• 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 Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015461429 [Primary]

FDA Product Code

• LSY: Ultrasound,Hyperthermia, Cancer Treatment
• POH: Mr-Guided Focused Ultrasound System

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

On-Brand Devices [Neuro V2 Kit 3T for USA]

• 07290015461429: Kit for single use during a Neuro V2 treatment guided under 3T MRI guidance. Kit content: Part
• 07290015461511: Kit for single use during a Neuro V2 treatment guided under 3T MRI guidance. Kit content: Part