Duns Number:277433335
Device Description: A part of the fiducial fixation kit, the pin allows to prevent the rotation of the tempora A part of the fiducial fixation kit, the pin allows to prevent the rotation of the temporary implant insert.
Catalog Number
005.0335
Brand Name
neuro mate® - Bone fixation pin Diameter 3,5mm
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
ba9b6071-16ca-40ad-b8e2-a0b443eca4de
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 |