Duns Number:312623008
Device Description: The product RegistrationPointer Cranial is a navigated pointer probe for performing non-st The product RegistrationPointer Cranial is a navigated pointer probe for performing non-steril registration for imageguided surgical procedures. The RegistrationPointert Cranial is designed to be used with the Fiagon Navigationsystem. The instrument is an accessory to the Fiagon Navigation system produced by fiagon GmbH.The instrument is 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
RegistrationPointer Cranial
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,K151156
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
10da3ab6-1bc1-44c7-8b2c-e1cf3dc59ad5
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 |