Neuro Protective Frame Pin Cup MPR001164

GUDID 07290015461306

single use silicon cups to protect head membrane from tearing by stereotactic frame sharp screws during FUS neuro clinical treatment

INSIGHTEC LTD

Therapeutic oncological/gynaecological ultrasound system

• Primary Device ID: 07290015461306
• NIH Device Record Key: 64465ad5-7759-4dae-8a55-b635c6536c67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuro Protective Frame Pin Cup
• Version Model Number: Neuro Protective Frame Pin Cup
• Catalog Number: MPR001164
• 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: 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 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	07290015461306 [Primary]

FDA Product Code

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

Sterilization

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

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461306]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-07-31

Devices Manufactured by INSIGHTEC LTD

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• 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