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Tracking Bracket Starter Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 667-132Ref 657-038Ref 657-044Ref 639-039Ref 667-130Ref 639-031Ref 657-056Ref 10441183Ref 657-074Ref 657-084
Identity
- Trade Name
- Tracking Bracket Starter Kit EUDAMEDFDA UDI
- Generic Name
- Electromagnetic surgical navigation device tracking system FDA UDIUltrasound imaging system tracking positioner, reusable FDA UDI
- Device Name
- Electromagnetic Tracking – Tracking Tools (Infiniti Plus Tracking Brackets) EUDAMEDElectromagnetic Tracking – Tracking Tools (Tracking Brackets) EUDAMEDElectromagnetic Tracking – Tracking Tools (UltraPro II Tracking Brackets) EUDAMEDElectromagnetic Tracking – Tracking Tools (Endocavity Tracking Brackets) EUDAMEDReusable non-sterile tracking bracket with (11.9 tapered to 3.8x61cm) CIV-Flex™ covers (5) for use with Samsung Medison EA2-11AR/EA2-11AV transducers FDA UDIReusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Samsung Medison L3-12A and LA3-12A transducers FDA UDIReusable non-sterile multi-angle PercuNav™ tracking bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) CIV-Flex™ covers (5) for use with Philips C5-1 transducers FDA UDIReusable non-sterile multi-angle tracking bracket with Ultra-Pro II™ Needle guides (5), (17.8 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 4C1 and 6C1 HD transducers FDA UDIReusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Samsung Medison LA4-18B transducers FDA UDIReusable non-sterile PercuNav™ tracking bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides(2), Infiniti Plus™ (18, 20, 21/22, 25GA) needle guides(3), (14 x 147cm) CIV-Flex™ covers(5) for use with Philips L12-5 transducer FDA UDIReusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Esaote PA240 transducers FDA UDIReusable non-sterile tracking bracket with (11.9 tapered to 3.8x61cm) CIV-Flex™ covers (5) for use with Samsung Medison E3-12A transducers FDA UDIReusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Esaote LA332 transducers FDA UDIReusable non-sterile tracking bracket with (11.9 tapered to 3.8 x 61cm) CIV-Flex™ covers (5), for use with Samsung Medison EA2-11AR/EA2-11AV transducers FDA UDI
- Model / Reference
- 657-074 EUDAMEDFDA UDI657-038 EUDAMEDFDA UDI667-130 EUDAMEDFDA UDI10441183 EUDAMEDFDA UDI657-044 EUDAMEDFDA UDI667-132 EUDAMEDFDA UDI639-039 EUDAMEDFDA UDI657-056 EUDAMEDFDA UDI639-031 EUDAMEDFDA UDI657-084 EUDAMEDFDA UDI
- Description
- Reusable non-sterile tracking bracket with (11.9 tapered to 3.8x61cm) CIV-Flex™ covers (5) for use with Samsung Medison EA2-11AR/EA2-11AV transducers FDA UDIReusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Samsung Medison L3-12A and LA3-12A transducers FDA UDIReusable non-sterile multi-angle PercuNav™ tracking bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) CIV-Flex™ covers (5) for use with Philips C5-1 transducers FDA UDIReusable non-sterile multi-angle tracking bracket with Ultra-Pro II™ Needle guides (5), (17.8 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 4C1 and 6C1 HD transducers FDA UDIReusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Samsung Medison LA4-18B transducers FDA UDIReusable non-sterile PercuNav™ tracking bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides(2), Infiniti Plus™ (18, 20, 21/22, 25GA) needle guides(3), (14 x 147cm) CIV-Flex™ covers(5) for use with Philips L12-5 transducer FDA UDIReusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Esaote PA240 transducers FDA UDIReusable non-sterile tracking bracket with (11.9 tapered to 3.8x61cm) CIV-Flex™ covers (5) for use with Samsung Medison E3-12A transducers FDA UDIReusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Esaote LA332 transducers FDA UDIReusable non-sterile tracking bracket with (11.9 tapered to 3.8 x 61cm) CIV-Flex™ covers (5), for use with Samsung Medison EA2-11AR/EA2-11AV transducers FDA UDI
Identifiers
- Catalog Number
- 657-074 FDA UDI657-038 FDA UDI667-130 FDA UDI10441183 FDA UDI657-044 FDA UDI667-132 FDA UDI639-039 FDA UDI657-056 FDA UDI639-031 FDA UDI657-084 FDA UDI
- Primary DI / UDI-DI
- 00841436118811 EUDAMEDFDA UDI00841436106191 EUDAMEDFDA UDI00841436106740 EUDAMEDFDA UDI00841436100274 EUDAMEDFDA UDI00841436111171 EUDAMEDFDA UDI00841436106764 EUDAMEDFDA UDI00841436105668 EUDAMEDFDA UDI00841436113694 EUDAMEDFDA UDI00841436105583 EUDAMEDFDA UDI00841436120166 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD103A2eUK EUDAMED0841436101TD103A2bUD EUDAMED0841436101TD103A2aUB EUDAMED0841436101TD103A2dUH EUDAMED
- Direct Marketing DI
- 20841436115388 EUDAMED20841436115913 EUDAMED20841436117719 EUDAMED20841436115791 EUDAMED20841436115241 EUDAMED20841436116293 EUDAMED20841436118327 EUDAMED20841436115746 EUDAMED20841436118860 EUDAMED20841436120153 EUDAMED
- FDA Product Code
- IYO FDA UDIITX FDA UDI
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMEDZ11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Electromagnetic surgical navigation device tracking system FDA UDIUltrasound imaging system tracking positioner, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1570 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 UDIFDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 1.89 Inch FDA UDIHeight — 1.52 Inch FDA UDILength — 10.2 Centimeter FDA UDIHeight — 4.9 Centimeter FDA UDIHeight — 1.99 Inch FDA UDILength — 4.04 Inch FDA UDILength — 1.9 Inch FDA UDIWidth — 1.5 Inch FDA UDIHeight — 1.6 Inch FDA UDILength — 3.6 Inch FDA UDIHeight — 1.56 Inch FDA UDILength — 2.12 Inch FDA UDIWidth — 4.1 Centimeter FDA UDILength — 4.6 Centimeter FDA UDI
Category: Electromagnetic surgical navigation device tracking system
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 Electromagnetic surgical navigation device tracking system.
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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
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 (20)
- FDA UDI fbda8efd-6888-4126-b007-4cc93f7063cc 37 fields · synced Aug 4, 2026
- FDA UDI 6d09b203-ac27-456f-b795-20f7a83d85b6 38 fields · synced May 29, 2026
- FDA UDI e2dec8a3-1c22-42cc-b77d-d08ec526a8d5 38 fields · synced May 30, 2026
- FDA UDI d4b0c1de-8dd3-4256-895f-950a6144783b 38 fields · synced May 30, 2026
- FDA UDI ccdb5428-103f-4d07-b3d4-f1e305936bf2 38 fields · synced May 30, 2026
- FDA UDI 0edeedd4-cfd0-42ff-865c-92825392027a 38 fields · synced May 30, 2026
- FDA UDI 54c47f7b-30fb-47d3-b574-e32060008424 38 fields · synced May 30, 2026
- FDA UDI 90ec1f13-6ba4-4497-bad5-1d9997a6e80e 37 fields · synced May 30, 2026
- FDA UDI 0637a0bd-5966-4b53-8134-4ed4abc1eb8c 38 fields · synced May 30, 2026
- FDA UDI 611ba955-0a6d-4a6c-92d7-44d4b4bf5270 37 fields · synced May 30, 2026
- EUDAMED 8ba80e8a-86ee-4cbe-bea1-93c51b61bc6f 61 fields · synced Jun 20, 2026
- EUDAMED bf93908c-0fc7-42aa-9a03-a40e6907fc58 61 fields · synced Jun 20, 2026
- EUDAMED 9651fa00-e73c-46c2-b3c7-878189eafc91 61 fields · synced Jul 9, 2026
- EUDAMED 25cb20f2-3a65-415c-8430-6cdac437c659 61 fields · synced Jul 9, 2026
- EUDAMED dac9a879-e439-4843-92b5-b3615488e787 61 fields · synced Jul 24, 2026
- EUDAMED 8b65b7be-17e1-44d7-8aff-fd555a43af8d 61 fields · synced Jul 25, 2026
- EUDAMED 3d102f88-0105-4414-87a8-8882037a4620 61 fields · synced Jul 30, 2026
- EUDAMED 500583e0-40b0-429a-a138-595c0822f4c5 61 fields · synced Jul 31, 2026
- EUDAMED 8243be55-5820-46d7-91b4-5aeb4a3ac78d 61 fields · synced Aug 1, 2026
- EUDAMED a3453c02-e7d4-425a-af3a-f69c09c0aec2 61 fields · synced Aug 4, 2026