eTRAX™ Needle Sensor 5408134

GUDID 00841436100977

Reusable non-sterile needle sensor for use with 3D Guidance driveBAY™ or trakSTAR™ trackers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Electromagnetic surgical navigation device tracking system

• Primary Device ID: 00841436100977
• NIH Device Record Key: b83f393f-7cb2-4134-b6d2-28658a9b9fdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eTRAX™ Needle Sensor
• Version Model Number: 5408134
• Catalog Number: 5408134
• Company DUNS: 134614411
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: +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: 7.7 Inch
• Needle Gauge: 16 Gauge
• Length: 7.7 Inch
• Needle Gauge: 16 Gauge
• Length: 7.7 Inch
• Needle Gauge: 16 Gauge
• Length: 7.7 Inch
• Needle Gauge: 16 Gauge
• Length: 7.7 Inch
• Needle Gauge: 16 Gauge
• Length: 7.7 Inch
• Needle Gauge: 16 Gauge
• Length: 7.7 Inch
• Needle Gauge: 16 Gauge
• Length: 7.7 Inch
• Needle Gauge: 16 Gauge
• Length: 7.7 Inch
• Needle Gauge: 16 Gauge
• Length: 7.7 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436100977 [Primary]

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

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• 00841436101127: Reusable non-sterile needle sensor for use with 3D Guidance driveBAY™ or trakSTAR™ trackers
• 00841436100977: Reusable non-sterile needle sensor for use with 3D Guidance driveBAY™ or trakSTAR™ trackers