Duns Number:108179458
Device Description: microTargeting STar Drive Array Electrode Insertion Tube with Stylet, 5x, Sterile, for use microTargeting STar Drive Array Electrode Insertion Tube with Stylet, 5x, Sterile, for use with Nexframe and STar Drive. Each Kit Contains: IT(AR22): Guide Tube - 1.83mm OD, 0.97mm ID (does not enter brain)IT(AR23): Insertion Tube w/ Stylet - 208mm length, 0.90mm OD, 0.60mm ID
Catalog Number
FC9001
Brand Name
microTargeting™ STar™ Insertion Tube
Version/Model Number
FC9001-00121
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 10, 2023
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
K092562,K092562
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
4fcfe124-3a0d-4cad-a5e2-0dba9f889670
Public Version Date
December 20, 2019
Public Version Number
4
DI Record Publish Date
August 22, 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 |
|---|---|---|
| 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 |