Duns Number:108179458
Device Description: 2.0 mm O.D. Verification Probe, 1xfor use with microTargeting™ STar™ Drive and microTarget 2.0 mm O.D. Verification Probe, 1xfor use with microTargeting™ STar™ Drive and microTargeting™ Platform
Catalog Number
66-IT-VP-03
Brand Name
microTargeting™ Verification Probe
Version/Model Number
66-IT-VP-03-00845
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
0fa8a0b4-7d22-411b-97dd-81a09d577178
Public Version Date
November 05, 2021
Public Version Number
1
DI Record Publish Date
October 28, 2021
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 |