← Back to catalogue
omniTRAX Patient Tracker Starter Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 5438658Ref 610-1227
Identity
- Trade Name
- omniTRAX 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 CT) EUDAMEDReusable non-sterile multi-modality fiducial markers (5), reusable non-sterile general purpose electromagnetic sensor for use with 3D Guidance driveBAY™ , driveBAY™ 2, trakSTAR™ or trakSTAR™ 2 trackers FDA UDIReusable non-sterile multi-modality fiducial markers (5), reusable non-sterile general purpose electromagnetic sensor for use with 3D Guidance driveBAY™, driveBAY™ 2™, trakSTAR™ or trakSTAR™ 2 trackers FDA UDI
- Model / Reference
- 610-1227 EUDAMEDFDA UDI5438658 EUDAMEDFDA UDI
- Description
- Reusable non-sterile multi-modality fiducial markers (5), reusable non-sterile general purpose electromagnetic sensor for use with 3D Guidance driveBAY™ , driveBAY™ 2, trakSTAR™ or trakSTAR™ 2 trackers FDA UDIReusable non-sterile multi-modality fiducial markers (5), reusable non-sterile general purpose electromagnetic sensor for use with 3D Guidance driveBAY™, driveBAY™ 2™, trakSTAR™ or trakSTAR™ 2 trackers FDA UDI
Identifiers
- Catalog Number
- 610-1227 FDA UDI5438658 FDA UDI
- Primary DI / UDI-DI
- 00841436102636 EUDAMEDFDA UDI00841436101042 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD103C1NP EUDAMED
- Direct Marketing DI
- 20841436118174 EUDAMED
- 510(k) Number
- K092619 FDA UDI
- FDA Product Code
- IYO 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
- 892.1560 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 7 Inch FDA UDILength — 1.95 Inch FDA UDI
Category: Electromagnetic device tracking system spatial marker
omniTRAX 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™ Active Patient Tracker Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- omniTRAX Patient Tracker — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
Cleared under the same submission
K092619 also covers:
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
- General Purpose Sensor — CIVCO MEDICAL INSTRUMENTS CO., INC.
- General Purpose Sensor — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Siemens Endocavity Tracking Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Tracking Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Tracking Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Tracking Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Tracking Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Tracking Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Civco Medical Instruments Co., Inc.
Sources (4)
- FDA UDI 24df42b0-e2c8-477b-b61c-9db973f8ebe7 38 fields · synced Aug 2, 2026
- FDA UDI cf82057a-8340-4ba5-b36e-e67b816ad0ca 38 fields · synced May 30, 2026
- EUDAMED a0611224-1330-491c-88bb-2927f6da2ff1 61 fields · synced Jul 21, 2026
- EUDAMED 4c147857-7904-4f5d-a550-62d74d879f3f 61 fields · synced Aug 2, 2026