PointerShell 5 mm E012901

GUDID 04260759930379

The device PointerShell 5mm is an instrument tracker adapter for image guided surgery for instruments shafts of 4.7mm to 5mm. The device is accessory to the Cube 4D Navigation system.

Fiagon GmbH

Multi-purpose stereotactic surgery system

• Primary Device ID: 04260759930379
• NIH Device Record Key: 5f565595-ee14-4601-adf3-63be14384b65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PointerShell 5 mm
• Version Model Number: E012901
• Catalog Number: E012901
• 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	04260759930379 [Primary]
HIBCC	EFIAE0129011 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141456

FDA Product Code

• PGW: Ear, Nose, And Throat Stereotaxic Instrument

Sterilization

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

[04260759930379]

Moist Heat or Steam Sterilization

[04260759930379]

Moist Heat or Steam Sterilization

[04260759930379]

Moist Heat or Steam Sterilization

[04260759930379]

Moist Heat or Steam Sterilization

[04260759930379]

Moist Heat or Steam Sterilization

[04260759930379]

Moist Heat or Steam Sterilization

[04260759930379]

Moist Heat or Steam Sterilization

[04260759930379]

Moist Heat or Steam Sterilization

[04260759930379]

Moist Heat or Steam Sterilization

[04260759930379]

Moist Heat or Steam Sterilization

[04260759930379]

Moist Heat or Steam Sterilization

[04260759930379]

Moist Heat or Steam Sterilization

[04260759930379]

Moist Heat or Steam Sterilization

[04260759930379]

Moist Heat or Steam Sterilization

[04260759930379]

Moist Heat or Steam Sterilization

[04260759930379]

Moist Heat or Steam Sterilization

[04260759930379]

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 5 mm ]

• EFIAE0129011: The product, PointerShell 5 mm is a product variant for the navigation of shavers or surgical i
• 04260759930379: The device PointerShell 5mm is an instrument tracker adapter for image guided surgery for instru