FDA UDI
In Commercial Distribution
🇺🇸 United States
TrackX
DI: 00857088008318
·
Model: Calibrator 2.0
·
TRACKX TECHNOLOGY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TrackX
- Primary DI
- 00857088008318
- Version / Model
- Calibrator 2.0
- Catalog Number
- 302-3TX
- Company Name
- TRACKX TECHNOLOGY, LLC
- Labeler DUNS
- 080948525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-30
- Public Version
- 1
- Public Version Date
- 2021-01-07
- Public Version Status
- New
- Public Device Record Key
- 3f5a2306-c002-4ec1-949a-9beb229730f7
Device Description
The device consists of a sterile Calibrator that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | Radiology | 892.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58473 | Diagnostic x-ray digital imaging system workstation application software | An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857088008318 | GS1 |
Customer Contacts
- Phone
- 1-888-787-2259
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173736 | 000 |