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eTRAX™ Needle System Starter Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 610-1254Ref 10855227Ref 10441628Ref 5483544Ref 610-1801Ref 667-150Ref 10854388Ref 5451117Ref 667-149Ref 5483528
Identity
- Trade Name
- eTRAX™ Needle System Starter Kit EUDAMEDFDA UDI
- Generic Name
- Electromagnetic surgical navigation device tracking system FDA UDI
- Device Name
- Electromagnetic Tracking – Needle with Tip Tracking EUDAMEDReusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5), (7.6 tapered to 3.8 x 147cm) CIV-Flex™ covers for use with 3D Guidance driveBAY™ , driveBAY™ 2, trakSTAR™ or trakSTAR™ 2 trackers FDA UDIReusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5) and (7.6 tapered to 3.8 x 147 cm) CIV-Flex™ covers FDA UDIReusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5), (7.6 tapered to 3.8 x 147cm) CIV-Flex™ covers, Ultra-Pro e™ needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) FDA UDIReusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.6 tapered to 3.8 x 147cm) CIV-Flex™ covers for use with 3D Guidance driveBAY™ or trakSTAR™ trackers FDA UDIReusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.6 tapered to 3.8 x 147cm) CIV-Flex™ covers (5), Ultra-Pro e™ needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) FDA UDIReusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.8 tapered to 3.8 x 147cm) CIV-Flex™ covers for use with 3D Guidance driveBAY™ , driveBAY™ 2, trakSTAR™ , or trakSTAR™ 2 trackers FDA UDIReusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5) and (7.6 tapered to 3.8 x 147cm) CIV-Flex™ covers FDA UDIReusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5), (7.6 tapered to 3.8 x 147cm) CIV-Flex™ covers, Ultra-Pro e™ needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) FDA UDIReusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.8 tapered to 3.8 x 147cm) CIV-Flex™ covers for use with 3D Guidance driveBAY™, driveBAY™ 2, trakSTAR™, or trakSTAR™ 2 trackers FDA UDI
- Model / Reference
- 10855227 EUDAMEDFDA UDI5483544 EUDAMEDFDA UDI667-149 EUDAMEDFDA UDI610-1801 EUDAMEDFDA UDI5451117 EUDAMEDFDA UDI10441628 EUDAMEDFDA UDI610-1254 EUDAMEDFDA UDI667-150 EUDAMEDFDA UDI5483528 EUDAMEDFDA UDI10854388 EUDAMEDFDA UDI10855226 FDA UDI
- Description
- Reusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5), (7.6 tapered to 3.8 x 147cm) CIV-Flex™ covers for use with 3D Guidance driveBAY™ , driveBAY™ 2, trakSTAR™ or trakSTAR™ 2 trackers FDA UDIReusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5) and (7.6 tapered to 3.8 x 147 cm) CIV-Flex™ covers FDA UDIReusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5), (7.6 tapered to 3.8 x 147cm) CIV-Flex™ covers, Ultra-Pro e™ needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) FDA UDIReusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.6 tapered to 3.8 x 147cm) CIV-Flex™ covers for use with 3D Guidance driveBAY™ or trakSTAR™ trackers FDA UDIReusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.6 tapered to 3.8 x 147cm) CIV-Flex™ covers (5), Ultra-Pro e™ needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) FDA UDIReusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.8 tapered to 3.8 x 147cm) CIV-Flex™ covers for use with 3D Guidance driveBAY™ , driveBAY™ 2, trakSTAR™ , or trakSTAR™ 2 trackers FDA UDIReusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5) and (7.6 tapered to 3.8 x 147cm) CIV-Flex™ covers FDA UDIReusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5), (7.6 tapered to 3.8 x 147cm) CIV-Flex™ covers, Ultra-Pro e™ needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) FDA UDIReusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.8 tapered to 3.8 x 147cm) CIV-Flex™ covers for use with 3D Guidance driveBAY™, driveBAY™ 2, trakSTAR™, or trakSTAR™ 2 trackers FDA UDI
Identifiers
- Catalog Number
- 10855226 FDA UDI10855227 FDA UDI5483544 FDA UDI667-149 FDA UDI610-1801 FDA UDI5451117 FDA UDI10441628 FDA UDI610-1254 FDA UDI667-150 FDA UDI5483528 FDA UDI10854388 FDA UDI
- Primary DI / UDI-DI
- 00841436100533 EUDAMEDFDA UDI00841436101110 EUDAMEDFDA UDI00841436111034 EUDAMEDFDA UDI00841436103428 EUDAMEDFDA UDI00841436101073 EUDAMEDFDA UDI00841436100342 EUDAMEDFDA UDI00841436102797 EUDAMEDFDA UDI00841436111041 EUDAMEDFDA UDI00841436101103 EUDAMEDFDA UDI00841436100519 EUDAMEDFDA UDI00841436100526 FDA UDI
- Basic UDI-DI
- 0841436101TD103BLB EUDAMED
- Direct Marketing DI
- 20841436118082 EUDAMED20841436118099 EUDAMED20841436118167 EUDAMED20841436118105 EUDAMED20841436118143 EUDAMED20841436118075 EUDAMED20841436118068 EUDAMED
- 510(k) Number
- K092619 FDA UDI
- FDA Product Code
- IYO FDA UDI
- EMDN Code
- A018099 NEEDLES - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Electromagnetic surgical navigation device tracking system 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
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 — 17 Centimeter FDA UDINeedle Gauge — 14 Gauge FDA UDINeedle Gauge — 12 Gauge FDA UDILength — 7.7 Inch FDA UDINeedle Gauge — 18 Gauge FDA UDINeedle Gauge — 16 Gauge FDA UDILength — 7.4 Inch FDA UDI
Category: Electromagnetic surgical navigation device tracking system
eTRAX™ Needle System Starter Kit 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 Electromagnetic surgical navigation device tracking system.
- RTM 92 HS — I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE S.P.A. · Class IIb
- Nadeln / Needles — REDA Instrumente GmbH · Class I
- Nadeln / Needles — REDA Instrumente GmbH · Class I
- IA091S — ALFAMED SRL · Class IIa
- Nadeln / Needles — REDA Instrumente GmbH · Class I
- Needle Holder — Shandong Chengwu Medical Products Factory · Class I
- XR90 System, LOGIQ, Upgrade Kit — MediView XR · Class II
- Nadeln / Needles — REDA Instrumente GmbH · Class I
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 (21)
- FDA UDI fada4270-9669-4592-af23-be3c9829bc7d 38 fields · synced Sep 18, 2026
- FDA UDI e2aa3ef9-e986-49d0-b444-8a3f1ce0fdfb 38 fields · synced May 26, 2026
- FDA UDI c666844e-41bf-4d51-b091-d76d85ee826d 38 fields · synced May 29, 2026
- FDA UDI 87cfa6c2-36b6-4eec-9516-d93fecdb453a 38 fields · synced May 29, 2026
- FDA UDI 2904b34a-f1b5-4edc-92f8-585e8e05bbd2 38 fields · synced May 30, 2026
- FDA UDI 75da8954-b00c-470f-8db9-2f7a5f08e058 38 fields · synced May 30, 2026
- FDA UDI 4475d85b-2ef6-4d70-86df-c556a0c0a038 38 fields · synced May 30, 2026
- FDA UDI 3999c169-98e7-4a6b-8ef0-987d31a67bd9 38 fields · synced May 30, 2026
- FDA UDI 4e8b68a0-e641-4314-8fb6-b4f3ffd4f331 38 fields · synced May 30, 2026
- FDA UDI d861fd85-1e80-49e4-9eff-ad1ef999e0a4 38 fields · synced May 30, 2026
- FDA UDI 41e8c593-0723-4de6-8991-e6dcf8d0dfc7 38 fields · synced May 30, 2026
- EUDAMED 16df8ae4-2dd0-4109-91c4-4b7f805f508d 61 fields · synced Jul 9, 2026
- EUDAMED 5b1d70e4-0beb-4d4d-a62c-0326dd96a148 61 fields · synced Jul 9, 2026
- EUDAMED ab32c0e5-bcc0-4c54-aacd-39ae5afae93e 61 fields · synced Jul 10, 2026
- EUDAMED c1965ce5-be54-4095-a407-62c1580d903f 61 fields · synced Jul 12, 2026
- EUDAMED 175b2592-c1cc-4cda-afe5-e43e240f4bcd 61 fields · synced Jul 14, 2026
- EUDAMED d6206d7c-61ef-4985-916c-ab46cc145fe5 61 fields · synced Jul 18, 2026
- EUDAMED bad807bb-d1a6-452a-861f-723a7ae3e17c 61 fields · synced Jul 20, 2026
- EUDAMED 0f02292b-9e39-47f4-8545-bf067dbf11ad 61 fields · synced Jul 20, 2026
- EUDAMED 0d4dfb00-ba24-4639-a40a-d1976cc62b34 61 fields · synced Sep 17, 2026
- EUDAMED 98ca260e-6313-4c0f-8bea-3c74506292aa 61 fields · synced Sep 18, 2026