Duns Number:108179458
Device Description: microTargeting Staged Bilateral Platforms, nonsterile, patient customized
Catalog Number
MP-KIT-P-SB
Brand Name
microTargeting™ Platform
Version/Model Number
MP-KIT-P-SB-00423
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 24, 2019
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
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
K092192,K092192
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
a88ba93d-754c-4137-8b47-6c341d02ac81
Public Version Date
June 24, 2019
Public Version Number
5
DI Record Publish Date
September 17, 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 |