BiopsyPointer 250

GUDID EFIAN012051CUS1

The product BiopsyPointer 250 referred to as BiopsyPointer is a product variant for the navigation of neurosurgical brain biopsy cannulas. The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument are 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 ENT 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 IDEFIAN012051CUS1
NIH Device Record Key333ddc55-e80e-4ad3-98bb-5278891b48db
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiopsyPointer 250
Version Model Number1
Company DUNS312623008
Company NameFiagon GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEFIAN012051CUS0 [Direct Marking]
HIBCCEFIAN012051CUS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


[EFIAN012051CUS1]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-30
Device Publish Date2016-08-10

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