Ultra-Pro II™ Needle Guide 610-1296

GUDID 00841436103060

Sterile needle guide with (9 x 91.5cm) telescopically-folded CIV-Flex™ cover

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, single-use
Primary Device ID00841436103060
NIH Device Record Keyb291ad09-b81d-4a85-85ee-db8d0e59fa61
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltra-Pro II™ Needle Guide
Version Model Number610-1296
Catalog Number610-1296
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

Length1.3 Inch
Width1 Inch
Length1.3 Inch
Width1 Inch
Length1.3 Inch
Width1 Inch
Length1.3 Inch
Width1 Inch
Length1.3 Inch
Width1 Inch
Length1.3 Inch
Width1 Inch
Length1.3 Inch
Width1 Inch
Length1.3 Inch
Width1 Inch
Length1.3 Inch
Width1 Inch
Length1.3 Inch
Width1 Inch
Length1.3 Inch
Width1 Inch
Length1.3 Inch
Width1 Inch
Length1.3 Inch
Width1 Inch
Length1.3 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

Operating and Storage Conditions

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
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
GS100841436103060 [Package]
Contains: 10841436103067
Package: [24 Units]
In Commercial Distribution
GS110841436103067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

Ethylene Oxide


[00841436103060]

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 II™ Needle Guide]

00841436104432Sterile needle guide with (17.8 x 147cm) telescopically-folded CIV-Flex™ cover
00841436104340Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover
00841436104036Sterile needle guide
00841436104012Sterile needle guide with (8.9 x 91.5cm) CIV-Flex™ cover
00841436103992Sterile needle guide with (14 x 91.5cm) telescopically-folded CIV-Flex™ cover
00841436103886Sterile needle guide with (17.8 x 91.5cm) telescopically-folded CIV-Flex™ cover
00841436104487Sterile needle guide with (14 x 91.5cm) telescopically-folded CIV-Flex™ cover
00841436103794Sterile needle guide with (14 x 61cm) flat-folded CIV-Flex™ cover
00841436103060Sterile needle guide with (9 x 91.5cm) telescopically-folded CIV-Flex™ cover
00841436102445Sterile needle guide with (14 x 29.2cm) telescopically folded CIV-Flex™ wireless transducer co
00841436101981Sterile needle guide with (17.8 x 91.5cm) telescopically-folded CIV-Flex™ cover
00841436101974Sterile needle guide with (14 x 91.5cm) CIV-Flex™ cover

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