FDA UDI
In Commercial Distribution
🇺🇸 United States
neuro|mate® - CT Scanner Localizer
DI: 03662724000116
·
Model: Localizer
·
RENISHAW MAYFIELD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- neuro|mate® - CT Scanner Localizer
- Primary DI
- 03662724000116
- Version / Model
- Localizer
- Catalog Number
- 001.0010
- Company Name
- RENISHAW MAYFIELD
- Labeler DUNS
- 277433335
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-18
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6165f914-fe0a-4640-a394-0a153841d63f
Device Description
The imaging localizer is attached to the temporary implant insert when the patient goes into the CT scanner for use in the ultrasound Frameless mode. Delivered in a storage case.
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
- No
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 | 03662724000116 | GS1 |
Customer Contacts
- Phone
- +33437238900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132755 | 000 |