FlexPointer 1.5 Cranial

GUDID EFIAE012004CUS0

The products FlexPointer 1.5 Cranial is a product variant of a navigated pointer probe for image guided surgical procedures The instruments are accessories to the Fiagon Navigation system. The Navigation system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of cranial surgery can be identified relative to a CT or MR based model of the anatomy.

Fiagon GmbH

Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system

Primary Device ID	EFIAE012004CUS0
NIH Device Record Key	677ed434-6230-4ab8-9919-a7a9f60f1d70
Commercial Distribution Status	In Commercial Distribution
Brand Name	FlexPointer 1.5 Cranial
Version Model Number	1
Company DUNS	312623008
Company Name	Fiagon GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EFIAE012004CUS0 [Direct Marking]
HIBCC	EFIAE012004CUS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K151156

FDA Product Code

HAW	Neurological Stereotaxic Instrument