omniTRAX™ Active Patient Tracker Starter Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- omniTRAX™ Active Patient Tracker Starter Kit EUDAMEDFDA UDI
- Generic Name
- Electromagnetic device tracking system spatial marker FDA UDI
- Device Name
- Electromagnetic Tracking – Tools for Automated Image Fusion (Omnitrax MR) EUDAMEDNon-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 FDA UDI
- Model / Reference
- 5670091 EUDAMEDFDA UDI610-1299 FDA UDI
- 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 FDA UDI
Identifiers
- Catalog Number
- 610-1299 FDA UDI5670091 FDA UDI
- Primary DI / UDI-DI
- 00841436110952 EUDAMEDFDA UDI00841436111768 FDA UDI
- Basic UDI-DI
- 0841436101TD103C2NR EUDAMED
- Direct Marketing DI
- 20841436118174 EUDAMED
- 510(k) Number
- K143396 FDA UDI
- FDA Product Code
- LNH FDA UDIIYO FDA UDI
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Electromagnetic device tracking system spatial marker FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI892.1560 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 1.95 Inch FDA UDIWidth — 7 Inch FDA UDI
Category: Electromagnetic device tracking system spatial marker
omniTRAX™ Active Patient Tracker Starter Kit by Civco Medical Instruments Co., Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Electromagnetic device tracking system spatial marker.
- PHASOR — Phasor Health, LLC · Class II
- Registration Marker Kit, Sterile, Single — MediView XR · Class II
- omniTRAX Patient Tracker Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- omniTRAX Patient Tracker — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Civco Medical Instruments Co., Inc.
Sources (3)
- FDA UDI 4b9a4c07-2aeb-4ad0-94dc-1dceba26d003 38 fields · synced Jul 17, 2026
- FDA UDI 799ac35a-35a9-4e4f-9c9a-2b536576d7be 38 fields · synced May 29, 2026
- EUDAMED 3ade30ec-53e6-4621-bd64-6f96fd24827b 61 fields · synced Jul 17, 2026