PointerShell Universal E012904

GUDID 04260759930393

The device PointerShell Universal is an instrument tracker adapter for image guided surgery for instruments shafts of 2.5mm to 5mm. The device is accessory to the Cube 4D Navigation system.

Fiagon GmbH

Multi-purpose stereotactic surgery system

• Primary Device ID: 04260759930393
• NIH Device Record Key: aa73ffd5-55c7-4852-9457-10f0c2ee1da1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PointerShell Universal
• Version Model Number: E012904
• Catalog Number: E012904
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260759930393 [Primary]
HIBCC	EFIAE0129041 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160479

FDA Product Code

• PGW: Ear, Nose, And Throat Stereotaxic Instrument

Sterilization

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

[04260759930393]

Moist Heat or Steam Sterilization

[04260759930393]

Moist Heat or Steam Sterilization

[04260759930393]

Moist Heat or Steam Sterilization

[04260759930393]

Moist Heat or Steam Sterilization

[04260759930393]

Moist Heat or Steam Sterilization

[04260759930393]

Moist Heat or Steam Sterilization

[04260759930393]

Moist Heat or Steam Sterilization

[04260759930393]

Moist Heat or Steam Sterilization

[04260759930393]

Moist Heat or Steam Sterilization

[04260759930393]

Moist Heat or Steam Sterilization

[04260759930393]

Moist Heat or Steam Sterilization

[04260759930393]

Moist Heat or Steam Sterilization

[04260759930393]

Moist Heat or Steam Sterilization

[04260759930393]

Moist Heat or Steam Sterilization

[04260759930393]

Moist Heat or Steam Sterilization

[04260759930393]

Moist Heat or Steam Sterilization

[04260759930393]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-10
• Device Publish Date: 2024-09-02

On-Brand Devices [PointerShell Universal]

• EFIAE0129041: The productPointerShell Universal is a product variant for the navigation of shavers or surgic
• 04260759930393: The device PointerShell Universal is an instrument tracker adapter for image guided surgery for