Duns Number:312623008
Device Description: The product ShuntPointer is a product variant for the navigation of neurosurgical shunt pl The product ShuntPointer is a product variant for the navigation of neurosurgical shunt placement.The instruments are accessories to the Fiagon Navigation system.The Navigation system is indicated for any medical condition in which the use of stereotactic surgery may beappropriate, and where reference to a rigid anatomical structure in the field of cranial surgery can be identifiedrelative to a CT or MR based model of the anatomy.
Catalog Number
-
Brand Name
ShuntPointer
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
K151156,K163209,K151156,K163209
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
00a57522-9ae6-4da1-9aa8-eba695b0e4ae
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 |