FlexPointer 1.5 single use E 01 3004

GUDID EFIAE0130041

The product FlexPointer 1.5 single use is navigated pointer probe 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

• Primary Device ID: EFIAE0130041
• NIH Device Record Key: d55873ac-77e9-435d-b103-15047b5e16af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexPointer 1.5 single use
• Version Model Number: 1
• Catalog Number: E 01 3004
• Company DUNS: 312623008
• Company Name: Fiagon GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EFIAE0130041 [Primary]
HIBCC	EFIAE0130042 [Package]; Package: [5 Units]; In Commercial Distribution
HIBCC	EFIAE0130043 [Package]; Package: [20 Units]; In Commercial Distribution
HIBCC	EFIAE0130044 [Package]; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200041

FDA Product Code

• PGW: Ear, Nose, And Throat Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-21
• Device Publish Date: 2021-06-11

Devices Manufactured by Fiagon GmbH

• 04260759930119 - RegistrationPointer: 2024-09-10 The device RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guided surgical pro
• 04260759930126 - VirtuEye: 2024-09-10 The device VirtuEye is a device for non-tactile registration for image guided surgical procedures. The device is accessory to t
• 04260759930256 - Navigation Headrest Universal: 2024-09-10 Headrest for navigation. Navigation sensor support for image guided surgery. The device is accessory to the Cube 4D Navigation s
• 04260759930362 - PointerShell 4 mm: 2024-09-10 The device PointerShell 4mm is an instrument tracker adapter for image guided surgery for instruments shafts of 3.5mm to 4mm. Th
• 04260759930379 - PointerShell 5 mm: 2024-09-10 The device PointerShell 5mm is an instrument tracker adapter for image guided surgery for instruments shafts of 4.7mm to 5mm. Th
• 04260759930386 - PointerShell 3 mm: 2024-09-10 The device PointerShell 3mm is an instrument tracker adapter for image guided surgery for instruments shafts of 2.5mm to 3.4mm.
• 04260759930393 - PointerShell Universal: 2024-09-10 The device PointerShell Universal is an instrument tracker adapter for image guided surgery for instruments shafts of 2.5mm to 5
• 14260759930512 - Adhesive Pad: 2024-09-10 Adhesive pads for fixation of patient localizer for image guided surgery. The device is accessory to the Cube 4D Navigation syst