Duns Number:108179458
Device Description: microTargeting DP Stylet, nonsterile, for use with mT Drive and STar Drive
Catalog Number
66-ST-12
Brand Name
microTargeting™ Stylet
Version/Model Number
66-ST-12-00825
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K011775
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
8a24c1c8-1547-4269-a912-3218a8f5a7e3
Public Version Date
May 26, 2021
Public Version Number
2
DI Record Publish Date
March 05, 2021
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |