Duns Number:314482980
Device Description: The platform hosts one or more Brainlab Software Applications. It incorporates a computer The platform hosts one or more Brainlab Software Applications. It incorporates a computer and display unit to facilitate the display, exchange, processing and interaction with data and tracking for Imaged Guided Surgery (IGS) purposes.
Catalog Number
-
Brand Name
Kick 2 Navigation Station EM
Version/Model Number
18202
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"
-
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
K213989
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
bfcd0878-1e05-4a49-9ef1-aa3c950dea35
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
September 30, 2022
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 | 48 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 685 |