Duns Number:312623008
Device Description: The productPointerShell Universal is a product variant for the navigation of shavers or s The productPointerShell Universal is a product variant for the navigation of shavers or surgical instruments without motor in the handleThey are indicated for use with the Fiagon Navigation System using electromagnetic navigation.The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate,and where, reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT orMR based model of the anatomy.
Catalog Number
-
Brand Name
PointerShell Universal
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
K160479,K160479
Product Code
PGW
Product Code Name
Ear, Nose, And Throat Stereotaxic Instrument
Public Device Record Key
69aa8383-ae2e-436c-84df-e31384620e06
Public Version Date
October 25, 2022
Public Version Number
6
DI Record Publish Date
August 10, 2016
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 |