Duns Number:341702266
Device Description: The Navigation Software NOCA AR provides import of image sets, building the image-based mo The Navigation Software NOCA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
Catalog Number
U4 003
Brand Name
NOVA AR
Version/Model Number
2.6.16
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
PGW
Product Code Name
Ear, Nose, And Throat Stereotaxic Instrument
Public Device Record Key
acff30d2-184c-4598-b8f7-e03e46d226d4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 20, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |