Identity
- Trade Name
- Tracking Bracket Starter Kit EUDAMEDFDA UDI
- Generic Name
- Ultrasound imaging system tracking positioner, reusable FDA UDI
- Device Name
- Electromagnetic Tracking – Tracking Tools (Tracking Brackets) EUDAMEDReusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Samsung Medison CA3-10A transducers FDA UDI
- Model / Reference
- 657-048 EUDAMEDFDA UDI
- Description
- Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Samsung Medison CA3-10A transducers FDA UDI
Identifiers
- Catalog Number
- 657-048 FDA UDI
- Primary DI / UDI-DI
- 00841436112192 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD103A2bUD EUDAMED
- Direct Marketing DI
- 20841436118402 EUDAMED
- 510(k) Number
- K092619 FDA UDI
- FDA Product Code
- IYO FDA UDI
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
- GMDN Term
- Ultrasound imaging system tracking positioner, reusable FDA UDI
Classification
- Device Class
- Class IIa 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
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
Category: Ultrasound imaging system tracking positioner, reusable
Tracking Bracket Starter Kit by Civco Medical Instruments Co., Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Ultrasound imaging system tracking positioner, reusable.
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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
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 (2)
- FDA UDI d4ed9a94-e67d-4c46-a1c7-7c8b2f677231 37 fields · synced Oct 7, 2026
- EUDAMED 9fdb0e19-3a6a-472d-9e33-ef56671a3d3f 61 fields · synced Oct 7, 2026