Identity
- Trade Name
- General Purpose Sensor EUDAMEDFDA UDI
- Generic Name
- Patient positioning sensor FDA UDI
- Device Name
- Electromagnetic Tracking – Tracking Tools (General Purpose Sensor) EUDAMEDNon-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY™ , driveBAY™ 2, trakSTAR™ , or trakSTAR™ 2 trackers FDA UDI
- Model / Reference
- 610-1066 EUDAMEDFDA UDI
- Description
- Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY™ , driveBAY™ 2, trakSTAR™ , or trakSTAR™ 2 trackers FDA UDI
Identifiers
- Catalog Number
- 610-1066 FDA UDI
- Primary DI / UDI-DI
- 00841436101912 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD103A1NH EUDAMED
- Direct Marketing DI
- 20841436118174 EUDAMED
- 510(k) Number
- K092619 FDA UDI
- FDA Product Code
- IYO FDA UDI
- EMDN Code
- A018099 NEEDLES - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Patient positioning sensor 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Width — 7 Inch FDA UDILength — 1.95 Inch FDA UDI
Category: Patient positioning sensor
General Purpose Sensor by Civco Medical Instruments Co., Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Patient positioning sensor.
- NGENIUS — Stryker Leibinger · Class II
- EV1000 — Edwards Lifesciences LLC · Class II
- Sherlock — Bard Access Systems, Inc. · Class II
- V40 — MAKO Surgical Corp. · Class II
- Patient tracker EM-D mini — Scopis GmbH · Class II
- Sherlock — Bard Access Systems, Inc. · Class II
- Calibration End Effector Inverted — MAKO Surgical Corp. · Class II
- Sherlock — Bard Access Systems, 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 |
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Manufacturer
- Manufacturer
- Civco Medical Instruments Co., Inc.
Sources (2)
- FDA UDI f9788593-65e3-420a-a5d3-25314a6ab940 38 fields · synced Jul 13, 2026
- EUDAMED 7e9fa451-831e-4bf4-bbb3-28b697b15532 61 fields · synced Jul 13, 2026