Tracking Bracket 653-002

GUDID 00841436106054

Sterile tracking bracket for use with Hologic ATEC biopsy instrument

CIVCO MEDICAL INSTRUMENTS CO., INC.

Ultrasound imaging system tracking holder, reusable

• Primary Device ID: 00841436106054
• NIH Device Record Key: caee5bab-23cc-4adb-94fb-b345133f99d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tracking Bracket
• Version Model Number: 653-002
• Catalog Number: 653-002
• 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: 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
• 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: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter
• Length: 5.7 Centimeter
• Width: 4.6 Centimeter

Operating and Storage Conditions

• 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
• 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	00841436106054 [Package]; Contains: 10841436106051; Package: [12 Units]; In Commercial Distribution
GS1	10841436106051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092619
• Premarket Notification: K970514

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2017-08-22

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