AccessGUDID - DEVICE: Navigation Headrest Office (EFIAE0110081)

GUDID

Device Identifier (DI) Information

Brand Name: Navigation Headrest Office
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fiagon GmbH

Primary DI Number: EFIAE0110081
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312623008 *Terms of Use

Device Description: The Navigation headrest is mounted on the procedurechairs instead It comprises a holder for a Navigatin sensor, which creates an electromagnetic field above the cushion of the Navigation headrest. The navigation headrest Office comes with the following adapters: 1) Chair Adapter A 2) Chair Adapter B 3) Chair Adapter C 4) Chair Adapter D 5) Chair Adapter E 6) Chair Adapter F 7) Chair Adapter R

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 85cc238c-2c94-4284-9178-5a788a6edd9b
Public Version Date: September 18, 2023
Public Version Number: 3
DI Record Publish Date: January 22, 2022