omniTRAX Active Patient Tracker 610-1306

GUDID 00841436103121

Non-sterile marker with CIVCO general purpose sensor connection for use in MR and US environments

CIVCO MEDICAL INSTRUMENTS CO., INC.

Electromagnetic device tracking system fiducial marker

• Primary Device ID: 00841436103121
• NIH Device Record Key: 0302514c-028b-46ad-b344-097a76583ee9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: omniTRAX Active Patient Tracker
• Version Model Number: 610-1306
• Catalog Number: 610-1306
• Company DUNS: 134614411
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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
• 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
• 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

• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch
• Width: 3.19 Inch
• Length: 3.39 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436103121 [Package]; Contains: 10841436103128; Package: [12 Units]; In Commercial Distribution
GS1	10841436103128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143396

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-09-06
• Device Publish Date: 2017-08-22

Devices Manufactured by CIVCO MEDICAL INSTRUMENTS CO., INC.

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• 20841436125066 - Biopsy Bracket: 2024-09-17 Reusable non-sterile Verza™ bracket for use with Esaote L 8-24 transducers
• 20841436122140 - Biopsy Bracket: 2024-06-28 Reusable non-sterile Verza™ bracket for use with Hologic® C9-2X transducers
• 20841436123284 - Needle Guide Bracket: 2024-06-28 Reusable non-sterile Infiniti Plus™ bracket for use with Siemens HLX transducers
• 00841436122214 - Needle Guide: 2024-06-28 Sterile endocavity needle guide for use with GE Healtcare E72, E721, EC8, E8C-RS, E8CS, IC5-9-D, IC5-9H, IC9B-RS, MTZ, and MZ t
• 00841436123051 - Needle Guide: 2024-06-28 Sterile endocavity needle guide for use with GE Healtcare IC9 transducers. One-cell MEA: =80% embryo developed to expand cytob
• 00841436123068 - Needle Guide: 2024-06-28 Sterile endocavity needle guide for use with GE Healtcare RIC5-9-D, RIC5-9W-RS. RIC6-12-D and Samsung Medison EV3-10B, V5-9 tra