Duns Number:277433335
Device Description: The drill is used to create a hole in the patient's skull to screw the temporary implant i The drill is used to create a hole in the patient's skull to screw the temporary implant insert.
Catalog Number
039.0345
Brand Name
neuro mate® - Bone fixation drill 3mm
Version/Model Number
Fiducial fixation kit
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 19, 2016
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
e1fed502-52eb-4f0f-8133-19952118c7ea
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 |