FDA UDI
In Commercial Distribution
🇺🇸 United States
omniTRAX™ Active Patient Tracker Starter Kit
DI: 00841436110952
·
Model: 5670091
·
CIVCO MEDICAL INSTRUMENTS CO., INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- omniTRAX™ Active Patient Tracker Starter Kit
- Primary DI
- 00841436110952
- Version / Model
- 5670091
- Catalog Number
- 5670091
- Company Name
- CIVCO MEDICAL INSTRUMENTS CO., INC.
- Labeler DUNS
- 134614411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-22
- Public Version
- 5
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 799ac35a-35a9-4e4f-9c9a-2b536576d7be
Device Description
Non-sterile markers (5) for use with MR and US enviroments, reusable non-sterile general purpose electromagnetic sensor for use with 3D Guidance driveBAY™, drive BAY 2, trakstar™ or trakSTAR 2 trackers
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LNH | System, nuclear magnetic resonance imaging | Radiology | 892.1000 | 2 |
| IYO | System, imaging, pulsed echo, ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58246 | Electromagnetic device tracking system spatial marker | A non-powered, noninvasive device intended to provide a fixed reference point for the electromagnetic (EM) tracking of a patient and/or instruments during a surgically-invasive procedure, whereby tracking images are overlaid on pre-acquired and/or real-time images [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US)]. Also referred to as a navigation fiducial marker or tracker, it typically consists of a radiopaque bracket-like device with an adhesive backing that is placed on the patient and allows the connection of an EM sensor for active registration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841436110952 | GS1 | ||||
| Direct Marking | 20841436118174 | GS1 |
Customer Contacts
- Phone
- +1(319)248-6502
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143396 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 7 | Inch | |
| Length | 1.95 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 52 – 85 Degrees Fahrenheit