BX2 Needle Guide 644-094, 644-094-5

GUDID 00841436120050

Sterile needle guide with (14x91.5cm) CIV-Flex cover for use with Hitachi C23 and C23RV transducer

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, single-use

Primary Device ID	00841436120050
NIH Device Record Key	9c0b233a-2934-4a2d-aa41-55901c2e22f1
Commercial Distribution Status	In Commercial Distribution
Brand Name	BX2 Needle Guide
Version Model Number	644-094
Catalog Number	644-094, 644-094-5
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	true
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

Device Dimensions

Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter
Width	91.5 Centimeter
Length	14 Centimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436120050 [Package] Contains: 10841436120057 Package: [12 Units] In Commercial Distribution
GS1	00841436120067 [Package] Package: [5 Units] In Commercial Distribution
GS1	10841436120057 [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

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

[00841436120050]

Ethylene Oxide

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-01-29
Device Publish Date	2021-01-21

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