General Purpose Sensor 10441627

GUDID 00841436100335

Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY™ , driveBAY™ 2, trakSTAR™ , or trakSTAR™ 2 trackers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Patient positioning sensor

• Primary Device ID: 00841436100335
• NIH Device Record Key: 47c71192-6dfc-43f0-be96-5d733f2d4de0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: General Purpose Sensor
• Version Model Number: 10441627
• Catalog Number: 10441627
• Company DUNS: 134614411
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com

Device Dimensions

• Length: 1.95 Inch
• Width: 7 Inch
• Length: 1.95 Inch
• Width: 7 Inch
• Length: 1.95 Inch
• Width: 7 Inch
• Length: 1.95 Inch
• Width: 7 Inch
• Length: 1.95 Inch
• Width: 7 Inch
• Length: 1.95 Inch
• Width: 7 Inch
• Length: 1.95 Inch
• Width: 7 Inch
• Length: 1.95 Inch
• Width: 7 Inch
• Length: 1.95 Inch
• Width: 7 Inch
• Length: 1.95 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436100335 [Primary]
GS1	20841436118174 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092619

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: 2017-08-22

On-Brand Devices [General Purpose Sensor]

• 00841436109390: Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY™
• 00841436101912: Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY™
• 00841436100984: Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY™
• 00841436100335: Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY™