FDA UDI
In Commercial Distribution
🇺🇸 United States
neuro|mate® - Fiducial fixation Kit
DI: 03662724000130
·
Model: Fiducial fixation kit
·
RENISHAW MAYFIELD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- neuro|mate® - Fiducial fixation Kit
- Primary DI
- 03662724000130
- Version / Model
- Fiducial fixation kit
- Catalog Number
- 001.0017
- Company Name
- RENISHAW MAYFIELD
- Labeler DUNS
- 277433335
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-18
- Public Version
- 1
- Public Version Date
- 2018-07-19
- Public Version Status
- New
- Public Device Record Key
- 1a3ffb24-c3d4-4dca-8803-9bf366fac0e6
Device Description
The kit is only used for the ultrasound Frameless registration. The fiducial fixation kit comprises a temporary implant insert, a screwdriverfor the temporary implant insert, four pins, a screwdriver for the pins, a drill, a stop collar, a screwdriver for the stop collar and a sterilization container.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32568 | Neurological stereotactic surgery system | An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03662724000130 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132755 | 000 |