Duns Number:108179458
Device Description: microTargeting DP Stylet, 1x, nonsterile, for use with mT Drive and STar Drive
Catalog Number
66-ST-14P
Brand Name
microTargeting™ Stylet
Version/Model Number
66-ST-14P-00237
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 11, 2021
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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,K011775
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
dad32deb-7c8f-46f9-be46-54d4e259e093
Public Version Date
February 12, 2021
Public Version Number
4
DI Record Publish Date
September 17, 2016
Package DI Number
10873263002374
Quantity per Package
5
Contains DI Package
00873263002377
Package Discontinue Date
February 11, 2021
Package Status
Not in Commercial Distribution
Package Type
PK/5
| 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 |