Duns Number:277433335
Device Description: neuro mate® is an image-guided, computer-controlled, 5-axis articulated arm. It is intende 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.
Catalog Number
-
Brand Name
neuro mate® frameless Gen II stereotactic system
Version/Model Number
neuro mate v1.5
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132755
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
94195827-c2b0-4f6a-86e9-327a5f8b391c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 31 |