Duns Number:277433335
Device Description: A part of the fiducial fixation kit, the long stop collar is fixed on the drill in order t A part of the fiducial fixation kit, the long stop collar is fixed on the drill in order to limit the depth of the drill.
Catalog Number
005.0661
Brand Name
neuro mate® - Long stop collar for drill
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
0a8ff437-1b6f-458b-90fe-9d554ca835a2
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 |