AccessGUDID - DEVICE: Navigation Headrest Universal (EFIAE0110031)

GUDID

Device Identifier (DI) Information

Brand Name: Navigation Headrest Universal
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Fiagon GmbH

Primary DI Number: EFIAE0110031
Issuing Agency: HIBCC
Commercial Distribution End Date: September 10, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 312623008 *Terms of Use

Device Description: The Navigation headrest is mounted on the OR table instead of the original headrest. It comprises of a sensor, which creates an electromagnetic field above the cushion of the Navigation headrest. The navigation headrest Universal comes with the following adapters: 1) Adapters for siderails 2)Adapters for Mizuho/Skytron Tables 3)Adapters for Maquet Tables 4)Adapters for Steris table 5)Adapters for Eschmann Tables 6)Flexarm adapters for for navigation sensor

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

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Product Code	Product Code Name
HAW	Neurological Stereotaxic Instrument
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
Storage 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: 9.6 Kilogram
Height: 120 Millimeter
Width: 300 Millimeter
Length: 550 Millimeter

Device Record Status

Public Device Record Key: 07a62d4c-6d3d-4d03-99d8-5ccc3176d1ee
Public Version Date: September 10, 2024
Public Version Number: 7
DI Record Publish Date: August 05, 2016