FDA.reportPublic FDA data

omniTRAX™ Active Patient Tracker Starter Kit

Primary DI
00841436110952
Brand
omniTRAX™ Active Patient Tracker Starter Kit
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
5670091
Catalog number
5670091
Device description
Non-sterile markers (5) for use with MR and US enviroments, reusable non-sterile general purpose electromagnetic sensor for use with 3D Guidance driveBAY™, drive BAY 2, trakstar™ or trakSTAR 2 trackers
Published
2017-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, imaging, pulsed echo, ultrasonic
LNHSystem, nuclear magnetic resonance imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143396000omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions2015-01-23IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841436118174Direct MarkingGS10
00841436110952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084143611817420841436118174
00841436110952008414361109528414361109520841436110952

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic device tracking system fiducial markerA non-sterile device intended to be used with an electromagnetic device tracking system to provide a physician with an external fixed reference point on the patient's body for the electromagnetic (EM) tracking of instruments inside the patient using pre-acquired images [e.g., computed tomography (CT) or magnetic resonance imaging (MRI)], or real-time image data and to join the imported CT and MRI images with real-time ultrasound (US). It typically consists of a radiopaque bracket-like device with an adhesive backing that is placed on the patient and allows the connection of an EM sensor for active registration. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.95Inch
Width7Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight
Storage Environment Temperature52 Degrees Fahrenheit85 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(319)248-6502regulatory@civco.com

Regulatory Flags#

DUNS number
134614411
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841436122078Biopsy Bracket653-004653-0042026-07-27
00841436122900Biopsy Bracket639-065639-0652026-07-27
00841436124294Biopsy Bracket642-520642-5202026-07-27
00841436125420Tracking Bracket657-107657-1072026-07-27
00841436125895Needle Guide Starter Kit658-009658-0092026-07-27
00841436126052Biopsy Bracket657-111657-1112026-07-27
00841436126212Tracking Bracket Starter Kit657-113657-1132026-07-27
00841436126229Tracking Bracket657-114657-1142026-07-27
00841436126328Tracking Bracket657-120657-1202026-07-27
00841436126366LED Instrument Cover610-2556610-25562026-07-27
00841436126403Needle Guide Starter Kit11713007117130072026-07-27
00841436126410Needle Guide Bracket11875211118752112026-07-27
00841436126588Tracking Bracket Starter KitH4927NFH4927NF2026-07-27
00841436126595Tracking Bracket642-528642-5282026-07-27
00841436127028Verza Guidance System11821685118216852026-07-27
00841436127035Biopsy Bracket676-254676-2542026-07-27
10841436125311CIV-Clear™ Transducer Cover610-2512610-2512, 610-2512-52026-07-27
10841436125915Needle Guide867-010867-010, 867-010-52026-07-27
10841436125939Needle Guide857-004857-004, 857-004-52026-07-27
10841436125953Needle Guide842-009842-009, 842-009-52026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112684C5-1FUJIFILM SONOSITE, INC.IYO2026-08-07
00816396022676WGS-100 Respiration PillowIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
00816396023550WGS-100 Wireless Gating SystemIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
00816396023567WGS-100 TransmitterIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
00816396023574WGS-100 Base StationIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
07090042059091nordicAktivaNordicneurolab ASLNH2026-08-03
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYO2026-07-24
00841436122672Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125338Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125819Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126281Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126304Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00866463000496STAGESpintech, Inc.LNH2026-07-23
00840432200216BladderScan®VERATHON INCIYO2026-07-22
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2026-07-10
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYO2026-06-24