EPIONE

GUDID 03760305400031

The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.

QUANTUM SURGICAL

Robotic surgical navigation system

• Primary Device ID: 03760305400031
• NIH Device Record Key: 4242fcce-ba19-4d20-bee8-4ac0b5f7f3a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIONE
• Version Model Number: 30-0001 v1.0.2
• Company DUNS: 268397609
• Company Name: QUANTUM SURGICAL
• 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: 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: +330448194050
• Email: contact@quantumsurgical.com
• Phone: +330448194050
• Email: contact@quantumsurgical.com
• Phone: +330448194050
• Email: contact@quantumsurgical.com
• Phone: +330448194050
• Email: contact@quantumsurgical.com
• Phone: +330448194050
• Email: contact@quantumsurgical.com
• Phone: +330448194050
• Email: contact@quantumsurgical.com
• Phone: +330448194050
• Email: contact@quantumsurgical.com
• Phone: +330448194050
• Email: contact@quantumsurgical.com
• Phone: +330448194050
• Email: contact@quantumsurgical.com
• Phone: +330448194050
• Email: contact@quantumsurgical.com
• Phone: +330448194050
• Email: contact@quantumsurgical.com
• Phone: +330448194050
• Email: contact@quantumsurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760305400031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223758

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-02
• Device Publish Date: 2023-05-25

On-Brand Devices [EPIONE]

• 03760305400086: The EPIONE device is a user controlled, stereotactic accessory intended to assist in the plannin
• 03760305400031: The EPIONE device is a user controlled, stereotactic accessory intended to assist in the plannin