AccuSITE Needle Guide 610-1017, 610-1030, 610-1123

GUDID 00841436102131

Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover

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

Primary Device ID	00841436102131
NIH Device Record Key	167ece4d-91a1-425d-87a9-2d967763af3d
Commercial Distribution Status	In Commercial Distribution
Brand Name	AccuSITE Needle Guide
Version Model Number	610-1017, 610-1030, 610-1123
Catalog Number	610-1017, 610-1030, 610-1123
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

Device Dimensions

Length	5.5 Inch
Width	3.3 Inch
Length	5.5 Inch
Width	3.3 Inch
Length	5.5 Inch
Width	3.3 Inch
Length	5.5 Inch
Width	3.3 Inch
Length	5.5 Inch
Width	3.3 Inch
Length	5.5 Inch
Width	3.3 Inch
Length	5.5 Inch
Width	3.3 Inch
Length	5.5 Inch
Width	3.3 Inch
Length	5.5 Inch
Width	3.3 Inch
Length	5.5 Inch
Width	3.3 Inch
Length	5.5 Inch
Width	3.3 Inch
Length	5.5 Inch
Width	3.3 Inch
Length	5.5 Inch
Width	3.3 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436101646 [Package] Contains: 10841436101643 Package: [24 Units] In Commercial Distribution
GS1	00841436101738 [Package] Contains: 00841436101646 Package: [5 Units] In Commercial Distribution
GS1	00841436102131 [Package] Contains: 00841436101738 Package: [12 Units] In Commercial Distribution
GS1	10841436101643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K093713

FDA Product Code

ITX	Transducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

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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00841436102551	Sterile needle guide with (14 x 29.2cm) telescopically-folded CIV-Flex™ wireless transducer co
00841436102506	Sterile needle guide with (14 x 29.2cm) telescopically-folded CIV-Flex™ wireless transducer co
00841436102155	Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover
00841436101653	Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover
00841436102131	Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover
00841436101752	Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover
00841436101738	Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover