Tracking Bracket Kit 667-147

GUDID 00841436106894

Sterile PercuNav™ tracking bracket and endocavity needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for use with Philips C10-4ec transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system

Primary Device ID	00841436106894
NIH Device Record Key	539b6341-76f4-42ad-98db-bbd428c032c6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Tracking Bracket Kit
Version Model Number	667-147
Catalog Number	667-147
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	true
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
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	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch
Width	1 Inch
Length	5.3 Inch

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
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436106894 [Package] Contains: 10841436106891 Package: [24 Units] In Commercial Distribution
GS1	10841436106891 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K092619

FDA Product Code

IYO	System, imaging, pulsed echo, ultrasonic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

Ethylene Oxide

[00841436106894]

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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