Identity
- Trade Name
- eTRAX™ Needle System Starter Kit FDA UDI
- Generic Name
- Electromagnetic surgical navigation device tracking system FDA UDI
- Device Name
- Reusable 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 UDI
- Model / Reference
- H4913NT FDA UDI
- Description
- Reusable 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 UDI
Identifiers
- Catalog Number
- H4913NT FDA UDI
- Primary DI / UDI-DI
- 00841436109468 FDA UDI
- 510(k) Number
- K092619 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Electromagnetic surgical navigation device tracking system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
- Needle Gauge — 18 Gauge FDA UDILength — 7.7 Inch FDA UDI
Category: Electromagnetic surgical navigation device tracking system
eTRAX™ Needle System Starter Kit by Civco Medical Instruments Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI 92eaabaa-637b-449b-a45f-1b298bb02353 38 fields · synced Jun 8, 2026