Integrated Needle Guide H46332LY, H46332LY-5

GUDID 00841436109093

Sterile needle guide with (17.8 x 147cm) telescopically-folded CIV-Flex™ cover for use with GE Healthcare C2-6b-D transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

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Primary Device ID	00841436109093
NIH Device Record Key	21a84946-7059-47c9-9d95-7cc0f74812de
Commercial Distribution Status	In Commercial Distribution
Brand Name	Integrated Needle Guide
Version Model Number	H46332LY, H46332LY-5
Catalog Number	H46332LY, H46332LY-5
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
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	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 Inch
Height	1.3 Inch
Length	1.4 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
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	00841436109093 [Package] Contains: 00841436109109 Package: [5 Units] In Commercial Distribution
GS1	00841436109109 [Package] Contains: 10841436109106 Package: [12 Units] In Commercial Distribution
GS1	10841436109106 [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

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

Ethylene Oxide

[00841436109093]

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

On-Brand Devices [Integrated Needle Guide]

00841436109093	Sterile needle guide with (17.8 x 147cm) telescopically-folded CIV-Flex™ cover for use with GE
00841436118705	Sterile needle guide with (17.8 x 147cm) telescopically-folded CIV-Flex™ cover for use with Ca