Localizer Headband - The product Localizer Headband is a product - Fiagon GmbH

Duns Number:312623008

Device Description: The product Localizer Headband is a product variant of a patient reference localisator.for The product Localizer Headband is a product variant of a patient reference localisator.for image guided surgical procedures.The navigation system and its accessories are intended for use by healthcare professionals only. In addition, theusers receive a training. The operator, i.e., the person or facility that is responsible for the use and service of thesystem, must ensure that all users of the system receive an adequate introduction into the system in accordance withvalid laws and regulations. An operator is everyone who uses the system.The localizer as a part of the navigation system serves as a reference fixed to the patient. The instructions for use ofthe navigation system describe the proper use of the entire system in detail.

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More Product Details

Catalog Number

-

Brand Name

Localizer Headband

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

eea92179-a8dc-4508-a51a-7337e8d5b3b6

Public Version Date

October 25, 2022

Public Version Number

5

DI Record Publish Date

August 05, 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