neuro|mate® frameless Gen II stereotactic system
Basic Information
- Brand Name
- neuro|mate® frameless Gen II stereotactic system
- Primary DI
- 03662724000024
- Version / Model
- neuro|mate v1.5
- Company Name
- RENISHAW MAYFIELD
- Labeler DUNS
- 277433335
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 94195827-c2b0-4f6a-86e9-327a5f8b391c
Device Description
neuro|mate® is an image-guided, computer-controlled, 5-axis articulated arm. It is intended for use in an operating room to position and orientate as prescribed by the surgeon a guide into which the surgeon can manually insert standard stereotactic instruments. neuro|mate® provides the surgeon with precise, reliable, and reproducible mechanical assistance in order to guide instruments during surgical interventions. neuro|mate® could be considered as a motorised stereotactic frame controlled by interactive PC-based imaging software which provides three-dimensional images of the anatomical structures of the brain as well as the target points. The neuro|mate® is a configurable medical device that is composed of a mobile support with or without a spacer, an arm, a planning trolley (with a planning station and a planning software), a remote control and cables.
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
- No
- 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 | 03662724000024 | GS1 |
Customer Contacts
- Phone
- +33437238900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132755 | 000 |