Clear Guide Optical Head

GUDID B201CGOH1

CLEAR GUIDE MEDICAL, INC.

Ultrasound imaging system application software Ultrasound imaging system application software Radiological video camera patient positioning/tracking system camera Radiological video camera patient positioning/tracking system camera Radiological video camera patient positioning/tracking system camera Radiological video camera patient positioning/tracking system camera Radiological video camera patient positioning/tracking system camera Radiological video camera patient positioning/tracking system camera Radiological video camera patient positioning/tracking system camera Radiological video camera patient positioning/tracking system camera Radiological video camera patient positioning/tracking system camera Radiological video camera patient positioning/tracking system camera Radiological video camera patient positioning/tracking system camera Radiological video camera patient positioning/tracking system camera Radiological video camera patient positioning/tracking system camera Radiological video camera patient positioning/tracking system camera

• Primary Device ID: B201CGOH1
• NIH Device Record Key: b2ac64ea-265b-42c1-a591-e29a1b2e2573
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clear Guide Optical Head
• Version Model Number: CGOH
• Company DUNS: 965399905
• Company Name: CLEAR GUIDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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
• 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
• 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	B201CGOH0 [Primary]
HIBCC	B201CGOH1 [Package]; Contains: B201CGOH0; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141806

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [Clear Guide Optical Head]

• B201CGOH1: CGOH
• B201CGOHM0: The device is intended as an accessory hardware to provide input into medical device software by