Duns Number:312623008
Device Description: The Navigation headrest is mounted on the procedurechairs instead It comprises a holder f The Navigation headrest is mounted on the procedurechairs instead It comprises a holder for a Navigatin sensor, whichcreates an electromagnetic field above the cushion of the Navigation headrest.The navigation headrest Office comes with the following adapters:1) Chair Adapter A2) Chair Adapter B3) Chair Adapter C4) Chair Adapter D5) Chair Adapter E6) Chair Adapter F7) Chair Adapter R
Catalog Number
-
Brand Name
Navigation Headrest Office
Version/Model Number
1
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
85cc238c-2c94-4284-9178-5a788a6edd9b
Public Version Date
October 25, 2022
Public Version Number
2
DI Record Publish Date
January 22, 2022
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. | 18 |