Duns Number:277433335
Device Description: Tool adaptor or guide bushing to accommodate various diameters of instruments. Only the di Tool adaptor or guide bushing to accommodate various diameters of instruments. Only the diameter of the central hole is adapted.
Catalog Number
005.0142
Brand Name
neuromate tool guide
Version/Model Number
Tool guide OD15 - Standard guide (XX = internal diameter)
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
32098361-b39c-4bef-952a-780eb1c28faf
Public Version Date
April 08, 2022
Public Version Number
4
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 |