Ultra-Pro 3™ Needle Guide 610-901, 610-938

GUDID 00841436104326

Sterile needle guide with (14 x 91.5cm) telescopically-folded CIV-Flex™ cover

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, single-use
Primary Device ID00841436104326
NIH Device Record Key99d101f2-5504-4d79-bd34-87dfe5648aac
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltra-Pro 3™ Needle Guide
Version Model Number610-901, 610-938
Catalog Number610-901, 610-938
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 Latexfalse
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
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

Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch
Length1.6 Inch
Height1.3 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436104326 [Package]
Contains: 10841436104323
Package: [24 Units]
In Commercial Distribution
GS100841436104500 [Package]
Package: [5 Units]
In Commercial Distribution
GS110841436104323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


[00841436104326]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-07
Device Publish Date2017-08-22

On-Brand Devices [Ultra-Pro 3™ Needle Guide]

00841436110235Sterile Needle Guide
00841436104456Sterile needle guide with (17.8 x 91.5cm) telescopically-folded CIV-Flex™ cover
00841436104449Ultra-Pro 3™ Needle Guide
00841436104326Sterile needle guide with (14 x 91.5cm) telescopically-folded CIV-Flex™ cover

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