eTRAX™ Needle System Starter Kit 610-1112

GUDID 00841436102063

Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.6 tapered to 3.8 x 147cm) CIV-Flex™ covers, Ultra-Pro e™ needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5)

CIVCO MEDICAL INSTRUMENTS CO., INC.

Electromagnetic surgical navigation device tracking system
Primary Device ID00841436102063
NIH Device Record Key9ca870aa-e10e-4e1c-9de2-f3137592aad0
Commercial Distribution StatusIn Commercial Distribution
Brand NameeTRAX™ Needle System Starter Kit
Version Model Number610-1112
Catalog Number610-1112
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 Usefalse
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

Device Dimensions

Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge
Length7.7 Inch
Needle Gauge16 Gauge

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
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
GS100841436102063 [Primary]
GS120841436118129 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, imaging, pulsed echo, ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-09-26
Device Publish Date2017-08-22

On-Brand Devices [eTRAX™ Needle System Starter Kit]

00841436111065Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5) and (7.6 tapered to
00841436111058Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5) and (7.6 tapered to
00841436111041Reusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5) and (7.6 tapered to 3.
00841436111034Reusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5) and (7.6 tapered to 3.
00841436109468Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5) (7.6 tapered to 3.8
00841436109383Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.6 tapered to 3.8
00841436103435Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.6 tapered to 3.8
00841436103428Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.6 tapered to 3.8
00841436103206Reusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5), (7.6 tapered to 3.8 x
00841436102063Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.6 tapered to 3.8
00841436101844Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.6 tapered to 3.8
00841436101110Reusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5), (7.6 tapered to 3.8 x
00841436101103Reusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5), (7.6 tapered to 3.8 x
00841436101073Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.6 tapered to 3.8
00841436100885Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.6 tapered to 3.8
00841436100533Reusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5) and (7.6 tapered to 3.
00841436100526Reusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5), (7.6 tapered to 3.8 x
00841436100519Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.8 tapered to 3.8
00841436100342Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.8 tapered to 3.8
20841436118082Reusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5) and (7.6 tapered to 3.

Trademark Results [eTRAX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ETRAX
ETRAX
97238952 not registered Live/Pending
John Daniel Associates, Inc.
2022-01-26
ETRAX
ETRAX
88783597 not registered Live/Pending
Operation Technology, Inc.
2020-02-03
ETRAX
ETRAX
78241295 not registered Dead/Abandoned
Terida Systems Inc.
2003-04-23
ETRAX
ETRAX
76010983 not registered Dead/Abandoned
Sky Desk, Inc.
2000-03-24
ETRAX
ETRAX
75351165 2576923 Live/Registered
AXIS AB
1997-09-03
ETRAX
ETRAX
72451765 0991947 Dead/Expired
TELESCIENCES, INC.
1973-03-16

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