Duns Number:108179458
Device Description: microTargeting Array Lead Insertion Tube with Stylet, 5x, Sterile, for Nexframe and STarDr microTargeting Array Lead Insertion Tube with Stylet, 5x, Sterile, for Nexframe and STarDrive
Catalog Number
FC9002
Brand Name
microTargeting™ Insertion Tube
Version/Model Number
FC9002-00767
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
c543ffe3-6304-43a6-813c-784e58eb76fd
Public Version Date
January 08, 2020
Public Version Number
1
DI Record Publish Date
December 31, 2019
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 |