eTRAX™ Needle 610-1615-01

GUDID 00841436103404

Sterile needle, 16GA x 15cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVCO 16GA needle sensor

CIVCO MEDICAL INSTRUMENTS CO., INC.

Soft-tissue biopsy procedure kit, non-medicated
Primary Device ID00841436103404
NIH Device Record Key29556ec1-14a3-462d-89d9-54e17d3ab74c
Commercial Distribution StatusIn Commercial Distribution
Brand NameeTRAX™ Needle
Version Model Number610-1615-01
Catalog Number610-1615-01
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

Device Dimensions

Length15 Centimeter
Needle Gauge16 Gauge
Length15 Centimeter
Needle Gauge16 Gauge
Length15 Centimeter
Needle Gauge16 Gauge
Length15 Centimeter
Needle Gauge16 Gauge
Length15 Centimeter
Needle Gauge16 Gauge
Length15 Centimeter
Needle Gauge16 Gauge
Length15 Centimeter
Needle Gauge16 Gauge
Length15 Centimeter
Needle Gauge16 Gauge
Length15 Centimeter
Needle Gauge16 Gauge
Length15 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436103404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, imaging, pulsed echo, ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841436103404]

Ethylene Oxide


[00841436103404]

Ethylene Oxide


[00841436103404]

Ethylene Oxide


[00841436103404]

Ethylene Oxide


[00841436103404]

Ethylene Oxide


[00841436103404]

Ethylene Oxide


[00841436103404]

Ethylene Oxide


[00841436103404]

Ethylene Oxide


[00841436103404]

Ethylene Oxide


[00841436103404]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-28

On-Brand Devices [eTRAX™ Needle]

00841436103541Sterile needle, 18GA x 17.7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with C
00841436103527Sterile needle, 18GA x 15cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103503Sterile needle, 18GA x 13cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103480Sterile needle, 18GA x 10cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103466Sterile needle, 18GA x 8cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC
00841436103442Sterile needle, 18GA x 6cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC
00841436103404Sterile needle, 16GA x 15cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103381Sterile needle, 16GA x 13cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103367Sterile needle, 16GA x 10cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103343Sterile needle, 16GA x 8cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC
00841436103329Sterile needle, 16GA x 6cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC
00841436103299Sterile needle, 14GA x 17cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103275Sterile needle, 14GA x 13cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103251Sterile needle, 14GA x 11cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103237Sterile needle, 14GA x 9cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC
00841436103213Sterile needle, 14GA x 7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC
00841436102520Sterile needle, 12GA x 17cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436102421Sterile needle, 12GA x 13cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436102360Sterile needle, 12GA x 9cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC
00841436102346Sterile needle, 12GA x 7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC
00841436101851Sterile needle, 16GA x 17.7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with C
00841436103510Sterile needle, 18GA x 13cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103497Sterile needle, 18GA x 10cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103473Sterile needle, 18GA x 8cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC
00841436103459Sterile needle, 18GA x 6cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC
00841436103374Sterile needle, 16GA x 10cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103350Sterile needle, 16GA x 8cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC
00841436103336Sterile needle, 16GA x 6cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC
00841436103268Sterile needle, 14GA x 11cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103244Sterile needle, 14GA x 9cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC
00841436103220Sterile needle, 14GA x 7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC
00841436102391Sterile needle, 12GA x 11cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436102377Sterile needle, 12GA x 9cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC
00841436102353Sterile needle, 12GA x 7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC
00841436103558Sterile needle, 18GA x 17.7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with C
00841436103534Sterile needle, 18GA x 15cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103411Sterile needle, 16GA x 15cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103398Sterile needle, 16GA x 13cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103305Sterile needle, 14GA x 17cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436103282Sterile needle, 14GA x 13cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436102537Sterile needle, 12GA x 17cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436102438Sterile needle, 12GA x 13cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV
00841436101868Sterile needle, 16GA x 17.7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with C

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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