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.

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Primary Device ID00841436120050
NIH Device Record Key9c0b233a-2934-4a2d-aa41-55901c2e22f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameBX2 Needle Guide
Version Model Number644-094
Catalog Number644-094, 644-094-5
Company DUNS134614411
Company NameCIVCO MEDICAL INSTRUMENTS CO., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com

Device Dimensions

Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter
Width91.5 Centimeter
Length14 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436120050 [Package]
Contains: 10841436120057
Package: [12 Units]
In Commercial Distribution
GS100841436120067 [Package]
Package: [5 Units]
In Commercial Distribution
GS110841436120057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-29
Device Publish Date2021-01-21

On-Brand Devices [BX2 Needle Guide]

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