Duns Number:277433335
Device Description: The kit is only used for the ultrasound Frameless registration. The fiducial fixation kit The kit is only used for the ultrasound Frameless registration. The fiducial fixation kit comprises a temporary implant insert, a screwdriverfor the temporary implant insert, four pins, a screwdriver for the pins, a drill, a stop collar, a screwdriver for the stop collar and a sterilization container.
Catalog Number
001.0017
Brand Name
neuro mate® - Fiducial fixation Kit
Version/Model Number
Fiducial fixation kit
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
1a3ffb24-c3d4-4dca-8803-9bf366fac0e6
Public Version Date
July 19, 2018
Public Version Number
1
DI Record Publish Date
June 18, 2018
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 |