FDA.reportPublic FDA data

omniTRAX Active Patient Tracker

Primary DI
00841436103121
Brand
omniTRAX Active Patient Tracker
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
610-1306
Catalog number
610-1306
Device description
Non-sterile marker with CIVCO general purpose sensor connection for use in MR and US environments
Published
2017-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNHSystem, nuclear magnetic resonance imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
00841436103121PackageGS112In Commercial Distribution
10841436103128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841436103121008414361031218414361031210841436103121
1084143610312810841436103128

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
Length3.39Inch
Width3.19Inch

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00866463000496STAGESpintech, Inc.LNH2026-07-23
04068151086584LungMapsSiemens Healthineers AGLNH2026-06-24
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.LNH2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.LNH2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.LNH2026-04-22
10841439114732PronumbraMEDTEC, INC.LNH2025-09-12
10841439114749PronumbraMEDTEC, INC.LNH2025-09-12
10841439114770PronumbraMEDTEC, INC.LNH2025-09-12
10841439114787PronumbraMEDTEC, INC.LNH2025-09-12