Fiagon Navigation Unit - The Fiagon Navigation System is intended as an - Fiagon GmbH

Duns Number:312623008

Device Description: The Fiagon Navigation System is intended as an aid for precisely locating anatomical struc

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More Product Details

Catalog Number

-

Brand Name

Fiagon Navigation Unit

Version/Model Number

CUBE4D

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

ab21864e-864c-4694-8f9f-32fdc7488a7d

Public Version Date

October 25, 2022

Public Version Number

3

DI Record Publish Date

May 12, 2020

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