Duns Number:108179458
Device Description: Multi-Oblique Platform 3.2mm Tool Guide (60mm), 1X
Catalog Number
66-MO-07
Brand Name
microTargeting™ Multi-Oblique Tool Guide
Version/Model Number
66-MO-07-00810
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
K092192,K092192
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
97b4487d-1bfc-4d11-a305-3d2da5e4bd34
Public Version Date
June 08, 2021
Public Version Number
2
DI Record Publish Date
October 06, 2020
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 |