AccessGUDID - DEVICE: Localizer Headband (EFIAE0122001)

GUDID

Device Identifier (DI) Information

Brand Name: Localizer Headband
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Fiagon GmbH

Primary DI Number: EFIAE0122001
Issuing Agency: HIBCC
Commercial Distribution End Date: July 18, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 312623008 *Terms of Use

Device Description: 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, the users receive a training. The operator, i.e., the person or facility that is responsible for the use and service of the system, must ensure that all users of the system receive an adequate introduction into the system in accordance with valid 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 of the navigation system describe the proper use of the entire system in detail.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45199	Multi-purpose stereotactic surgery system	An electrically-powered assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PGW	Ear, Nose, And Throat Stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 0.035 Kilogram
Height: 15 Millimeter
Width: 30 Millimeter
Length: 45 Millimeter

Device Record Status

Public Device Record Key: eea92179-a8dc-4508-a51a-7337e8d5b3b6
Public Version Date: September 18, 2023
Public Version Number: 7
DI Record Publish Date: August 05, 2016