Clear Guide CORE CG-CORE24-MR

GUDID B201CGCORE24MR0

The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.

CLEAR GUIDE MEDICAL, INC.

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• Primary Device ID: B201CGCORE24MR0
• NIH Device Record Key: 122bf2f4-3750-4694-947c-a08e77713994
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clear Guide CORE
• Version Model Number: CGCORE24MR
• Catalog Number: CG-CORE24-MR
• Company DUNS: 965399905
• Company Name: CLEAR GUIDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B201CGCORE24MR0 [Primary]
HIBCC	B201CGCORE24MR1 [Package]; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171677

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-14
• Device Publish Date: 2022-10-06

On-Brand Devices [Clear Guide CORE]

• B201CGCORE24MR0: The device is intended as a computer platform to perform computation, display, connectivity and
• B201CGCORE130: The device is intended as a computer platform to perform computation, display, connectivity and
• B201CGCORE240: The device is intended as a computer platform to perform computation, display, connectivity and
• B201CGCORE170: The device is intended as a computer platform to perform computation, display, connectivity and