RENISHAW MAYFIELD

Address:31 rue Ampere,Chassieu Rhone,FR

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Device Description : neuro mate® is an image-guided, computer-controlled, 5-axis articulated arm. It 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 Class : 2

Duns Number: 277433335

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

Device Description : The standard tool-holder is universal and features a guide bushing into which st The standard tool-holder is universal and features a guide bushing into which standard neurosurgical instruments may be inserted such as drills, tube-guides, biopsy instruments and catheters, etc.It can be sold and delivered with a sterilization container.

Device Class : 2

Duns Number: 277433335

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

Device Description : Screw used for the fixation of the tool-holder on the neuro mate® system.

Device Class : 2

Duns Number: 277433335

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

- Catalog Number : 005.0142

Device Description : Tool adaptor or guide bushing to accommodate various diameters of instruments. O Tool adaptor or guide bushing to accommodate various diameters of instruments. Only the diameter of the central hole is adapted.

Device Class : 2

Duns Number: 277433335

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

Device Description : Tightening screw used to lock the tool adaptor into the neuro mate tool-holder.

Device Class : 2

Duns Number: 277433335

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

- Catalog Number : 005.0606

Device Description : Long tool adaptor or guide bushing to accommodate various diameters of instrumen Long tool adaptor or guide bushing to accommodate various diameters of instruments. Only the diameter of the central hole is adapted.

Device Class : 2

Duns Number: 277433335

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

Device Description : The laser tool-holder is used to check the system's precision before beginning s The laser tool-holder is used to check the system's precision before beginning surgery. It is also used to indicate trajectory entry points on the skull's surface.Delivered in a storage case.

Device Class : 2

Duns Number: 277433335

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

Device Description : The registration tool-holder (or ultrasound tool-holder) is used during registra The registration tool-holder (or ultrasound tool-holder) is used during registration in ultrasound Frameless mode. Delivered in a storage case.

Device Class : 2

Duns Number: 277433335

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

Device Description : The registration frame (or microphone frame) is attached to the temporary implan The registration frame (or microphone frame) is attached to the temporary implant insert at the start of surgery in order to map the patient with the neuro mate® in the ultrasound Frameless mode. Delivered in a storage case.

Device Class : 2

Duns Number: 277433335

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

Device Description : The imaging localizer is attached to the temporary implant insert when the patie 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 Class : 2

Duns Number: 277433335

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1