FlexTube 3 single use

GUDID EFIAE0131042

The product is a single use navigated suction instrument for image guided surgical procedures. The instruments are intended as an aid for 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

ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system
Primary Device IDEFIAE0131042
NIH Device Record Key26c6d445-9d3e-4e1d-ac89-e5a71e2cc464
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexTube 3 single use
Version Model Number1
Company DUNS312623008
Company NameFiagon GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEFIAE0131041 [Primary]
HIBCCEFIAE0131042 [Package]
Contains: EFIAE0131041
Package: [5 Units]
In Commercial Distribution
HIBCCEFIAE0131043 [Package]
Contains: EFIAE0131041
Package: [20 Units]
In Commercial Distribution
HIBCCEFIAE0131044 [Package]
Contains: EFIAE0131041
Package: [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PGWEar, Nose, And Throat Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-21
Device Publish Date2021-06-11

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04260759930096 - RIWOtrack Flexsensor2024-01-15 Navigation probe, component of RIWOtrack Navigation System
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