ShuntPointer - The product ShuntPointer is a product variant for - Fiagon GmbH

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.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

ShuntPointer

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FIAGON GMBH" Characteristics
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