Duns Number:108179458
Device Description: STar(TM) Drive Frame Adapter for use with Leibinger RM stereotactic frame
Catalog Number
FC8005
Brand Name
STar™ Drive Frame Adapter
Version/Model Number
FC8005-00107
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 28, 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
-
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
894e868e-9f5d-4853-b572-02caeb3441dc
Public Version Date
July 29, 2021
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 |