FDA.reportPublic FDA data

Navigation Headrest Universal

Primary DI
EFIAE0110031
Brand
Navigation Headrest Universal
Company
Fiagon GmbH
Model
1
Device description
The Navigation headrest is mounted on the OR table instead of the original headrest. It comprises of a sensor, whichcreates an electromagnetic field above the cushion of the Navigation headrest.The navigation headrest Universal comes with the following adapters:1) Adapters for siderails2)Adapters for Mizuho/Skytron Tables3)Adapters for Maquet Tables4)Adapters for Steris table5)Adapters for Eschmann Tables6)Flexarm adapters for for navigation sensor
Published
2016-08-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument
PGWEar, Nose, And Throat Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2
PGWEar, Nose, And Throat Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EFIAE0110031PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose stereotactic surgery systemAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height120Millimeter
Length550Millimeter
Weight9.6Kilogram
Width300Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+13364282241support@fiagon.com

Regulatory Flags#

DUNS number
312623008
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260759931314Flexarm UniversalE0119732026-09-20
04260759931697VirtuEye ProE011440E0114402026-08-17
EFIAE0135061VenSure Balloon Sinus Dilation System1E 01 35062021-06-11
EFIAE0135161VenSure Nav Balloon Sinus Dilation System12021-06-11
04260759931246VenSure Balloon Dilation System1E 01 35262022-11-10
04260759931680VenSure 4D Balloon Dilation System1E 01 35662025-09-18
04260759931260VenSure Nav Balloon Dilation System1E 01 35462022-11-10
04260759931253VenSure Light Balloon Dilation System1E 01 35362022-10-14
EFIAE0135921Vensure Inflation Device1E 01 35922022-01-21
04260759930003Integrated HeadrestE0119702025-06-25
04260759930133Navigation Unit Cube4DE011106-HD/8E011106-HD/82025-01-16
042607599301574K Navigation Unit Cube4DE011106-4K/8E011106-4K/82025-01-16
04260759930249Navigation SensorA011000A0110002025-01-16
04260759930300FlexPointerE012002E0120022025-01-16
04260759930317FlexPointer 1.5 mmE012004E0120042025-01-16
04260759930324FlexTube 3mmE012104E0121042025-01-16
04260759930331FlexTube 4mmE012106E0121062025-01-16
04260759930348PointerTube KeatE012107E0121072025-01-16
04260759930355PointerTube KennedyE012108E0121082025-01-16
04260759930447Localizer Adhesive Pad C-TypeE012202CE012202C2025-01-16

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Primary DI, Brand, Company table
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