Duns Number:277433335
Device Description: The laser tool-holder is used to check the system's precision before beginning surgery. It 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.
Catalog Number
001.0111
Brand Name
neuro mate® - Laser tool-holder
Version/Model Number
Tool-holder
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"
-
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
126606f3-e6e5-412f-a0f5-20ac11da7d3c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 18, 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 |