Neuro Stereotactic Frame Posts ASM001395_6_7_8

GUDID 07290015461320

multi use posts connecting stereotactic frame with patient skull , threw screws, during neuro MRI guided FUS treatment Stereotactic Frame Posts ASM001395 (70mmL) ASM001396 (70mmR) ASM001397 (100mmL) ASM001398 (100mmR)

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: 07290015461320
• NIH Device Record Key: 140fa3a5-96a3-4fe5-a213-46d89e1f1ad8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuro Stereotactic Frame Posts
• Version Model Number: Neuro Stereotactic Frame Posts
• Catalog Number: ASM001395_6_7_8
• 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: false
• 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

Device Dimensions

• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 100 Millimeter
• Length: 70 Millimeter
• Length: 100 Millimeter
• Length: 70 Millimeter
• Length: 100 Millimeter
• Length: 70 Millimeter
• Length: 100 Millimeter
• Length: 70 Millimeter
• Length: 100 Millimeter
• Length: 70 Millimeter
• Length: 100 Millimeter
• Length: 70 Millimeter
• Length: 100 Millimeter
• Length: 70 Millimeter
• Length: 100 Millimeter
• Length: 70 Millimeter
• Length: 100 Millimeter
• Length: 70 Millimeter
• Length: 100 Millimeter
• Length: 70 Millimeter
• Length: 100 Millimeter
• Length: 70 Millimeter
• Length: 100 Millimeter
• Length: 70 Millimeter
• Length: 100 Millimeter
• Length: 70 Millimeter
• Length: 100 Millimeter
• Length: 70 Millimeter
• Length: 100 Millimeter
• Length: 70 Millimeter
• Length: 100 Millimeter
• Length: 70 Millimeter

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	07290015461320 [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

[07290015461320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[07290015461320]

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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• 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
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