RegistrationPointer - The products RegistrationPointer is a navigated - Fiagon GmbH

Duns Number:312623008

Device Description: The products RegistrationPointer is a navigated pointer probe for performing non-steril re The products RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guidedsurgical procedures. The instrument is part of the Fiagon Navigation – Extended instrument set ENT, which isdesigned to be used with the Fiagon Navigation system. The instrument is an accessory to the Fiagon Navigationsystem produced by Fiagon GmbH.The Fiagon Navigation - Extended Instrument Set ENT is intended as an aid for precisely locating anatomicalstructures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system usingelectromagnetic navigation.The Fiagon Navigation – Extended Instrument Set ENT is indicated for any medical condition in which the use ofstereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENTsurgery can be identified relative to a CT or MR based model of the anatomy.

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More Product Details

Catalog Number

-

Brand Name

RegistrationPointer

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

-

Product Code Details

Product Code

PGW

Product Code Name

Ear, Nose, And Throat Stereotaxic Instrument

Device Record Status

Public Device Record Key

24f31124-f4fc-47d4-8e56-f99a43ba5a3c

Public Version Date

October 25, 2022

Public Version Number

5

DI Record Publish Date

August 08, 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