Duns Number:108179458
Device Description: microTargeting(TM) Microtable(TM) Platform – Single
Catalog Number
66-MT-D1
Brand Name
microTargeting™ Microtable™ Platform – Single
Version/Model Number
66-MT-D1-00643
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2022
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
K132611
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
e091963c-5f33-48fc-aa9c-dca7e48b7509
Public Version Date
October 04, 2022
Public Version Number
4
DI Record Publish Date
January 23, 2018
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 |