Identity
- Trade Name
- Tracking Bracket FDA UDI
- Generic Name
- Electromagnetic surgical navigation device tracking system FDA UDI
- Device Name
- Reusable non-sterile tracking bracket for use with Samsung Medison CA1-7S transducers FDA UDI
- Model / Reference
- 657-083 FDA UDI
- Description
- Reusable non-sterile tracking bracket for use with Samsung Medison CA1-7S transducers FDA UDI
Identifiers
- Catalog Number
- 657-083 FDA UDI
- Primary DI / UDI-DI
- 00841436119993 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
No
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
Category: Electromagnetic surgical navigation device tracking system
Tracking Bracket by Civco Medical Instruments Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — 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 (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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Civco Medical Instruments Co., Inc.
Sources (1)
- FDA UDI 83880c00-db83-4bf4-b81e-cfec59d91903 37 fields · synced Jun 8, 2026