Ultra-Pro e™ Variable Angle Needle Guide 610-1083, 610-1221

GUDID 00841436101950

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

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 ID00841436101950
NIH Device Record Keyddd81f9f-9c59-4b83-a98d-3416d31951b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltra-Pro e™ Variable Angle Needle Guide
Version Model Number610-1083, 610-1221
Catalog Number610-1083, 610-1221
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

Needle Gauge16 Gauge
Length1.3 Inch
Needle Gauge16 Gauge
Length1.3 Inch
Needle Gauge16 Gauge
Length1.3 Inch
Needle Gauge16 Gauge
Length1.3 Inch
Needle Gauge16 Gauge
Length1.3 Inch
Needle Gauge16 Gauge
Length1.3 Inch
Needle Gauge16 Gauge
Length1.3 Inch
Needle Gauge16 Gauge
Length1.3 Inch
Needle Gauge16 Gauge
Length1.3 Inch
Needle Gauge16 Gauge
Length1.3 Inch
Needle Gauge16 Gauge
Length1.3 Inch
Needle Gauge16 Gauge
Length1.3 Inch
Needle Gauge16 Gauge
Length1.3 Inch
Needle Gauge16 Gauge
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

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
GS100841436101950 [Package]
Contains: 10841436101957
Package: [24 Units]
In Commercial Distribution
GS100841436102599 [Package]
Package: [5 Units]
In Commercial Distribution
GS110841436101957 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, imaging, pulsed echo, ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

Ethylene Oxide


[00841436101950]

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 e™ Variable Angle Needle Guide]

00841436102858Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover
00841436102834Sterile needle guide with (14 x 91.5cm) telescopically-folded CIV-Flex™ cover
00841436102827Sterile needle guide
00841436102247Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover
00841436102612Sterile needle guide with (14 x 91.5cm) telescopically-folded CIV-Flex™ cover
00841436102223Sterile needle guide
00841436102216Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover
00841436102209Sterile needle guide with (14 x 91.5cm) telescopically-folded CIV-Flex™ cover
00841436102193Sterile needle guide
00841436102018Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover
00841436102582Sterile needle guide with (14 x 91.5cm) telescopically-folded CIV-Flex™ cover
00841436101998Sterile needle guide
00841436101967Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover
00841436101950Sterile needle guide with (14 x 91.5cm) telescopically-folded CIV-Flex™ cover
00841436101943Ultra-Pro e™ Variable Angle Needle Guide

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