BX2 Needle Guide 680-112

GUDID 00841436107617

Sterile needle guide with (8.9 x 91.5cm) telescopically-folded CIV-Flex™ cover for use with Toshiba PVT-382BT transducer

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 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 Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use

Primary Device ID	00841436107617
NIH Device Record Key	aa8726d1-ea08-4881-97e0-1d3395502b57
Commercial Distribution Status	In Commercial Distribution
Brand Name	BX2 Needle Guide
Version Model Number	680-112
Catalog Number	680-112
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	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 Centimeter
Width	4.9 Centimeter
Length	5.7 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
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	00841436107617 [Package] Contains: 10841436107614 Package: [12 Units] In Commercial Distribution
GS1	10841436107614 [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

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

Ethylene Oxide

[00841436107617]

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

On-Brand Devices [BX2 Needle Guide]

00841436107617	Sterile needle guide with (8.9 x 91.5cm) telescopically-folded CIV-Flex™ cover for use with To
00841436120050	Sterile needle guide with (14x91.5cm) CIV-Flex cover for use with Hitachi C23 and C23RV transduc