Duns Number:835233107
Device Description: SFW KIT 9735739 STEALTH S8 STEREOTX
Catalog Number
-
Brand Name
StealthStation Cranial Software
Version/Model Number
9735739
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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"
Yes
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
K162309
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
516d1ae3-854b-4633-ad73-a03c7404aec4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 25, 2017
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1961 |
| 3 | A medical device with high risk that requires premarket approval | 1 |