Duns Number:108179458
Device Description: microTargeting STar Array Electrode Insertion Tube Set, Sterile, for use with Nexframe and microTargeting STar Array Electrode Insertion Tube Set, Sterile, for use with Nexframe and STar Drive. Contains: IT(DB7): Insertion Tube - 208mm tube length, 1.83mm od, 1.6mm id. PT(DB7): Protective Tube - 209mm tube length, 1.50mm od, .58mm id.
Catalog Number
70-IT-3007
Brand Name
microTargeting™ STar™ Inerstion Tube Set
Version/Model Number
70-IT-3007-00234
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
d9641ac1-3d6e-4437-a23a-7419e1d2685c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 17, 2016
Package DI Number
10873263002343
Quantity per Package
5
Contains DI Package
00873263002346
Package Discontinue Date
-
Package Status
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 |