VirtuTRAX Instrument Navigator 610-1153

GUDID 00841436102285

Sterile navigator with (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex™ sensor cover for use with 10-14GA instruments

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use 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	00841436102285
NIH Device Record Key	4e5001fe-91bf-480c-a234-d2c6c66004cd
Commercial Distribution Status	In Commercial Distribution
Brand Name	VirtuTRAX Instrument Navigator
Version Model Number	610-1153
Catalog Number	610-1153
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
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	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 Inch
Height	1.1 Inch
Length	5.5 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
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	00841436102285 [Package] Contains: 10841436102282 Package: [5 Units] In Commercial Distribution
GS1	10841436102282 [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

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

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[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

[00841436102285]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-10-07
Device Publish Date	2017-08-22

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00841436101882	Sterile navigator with (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex™ sensor cov
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