EPIONE RoboKit Plus

GUDID 03760305400253

The EPIONE® RoboKit™ Plus is used during the CT guided procedures performed with EPIONE®. Sterile drapes are used to cover: the robotic arm, the touchscreen of the display cart, the tray of the display cart supporting the mouse and the keyboard. Reflective spheres to be placed on the tracked EPIONE instruments tracked. The EPIONE® RoboKit™ Plus includes the accessories individually packaged in their primary packaging considered as sterile, but the EPIONE® RoboKit™ Plus is not sterile.

QUANTUM SURGICAL

Surgical optical-tracking spatial marker, single-use

• Primary Device ID: 03760305400253
• NIH Device Record Key: 35b4693b-3b64-49bc-a226-f81b8eee3d00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIONE RoboKit Plus
• Version Model Number: 09-0046
• Company DUNS: 268397609
• Company Name: QUANTUM SURGICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
GS1	03760305400253 [Primary]

FDA Product Code

• LRO: General Surgery Tray

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: 2024-12-16
• Device Publish Date: 2024-12-06

Devices Manufactured by QUANTUM SURGICAL

• 03760305400260 - EPIONE RoboKit: 2024-12-20 The EPIONE® RoboKit™ Plus is used during the CT guided procedures performed with EPIONE®. Sterile drapes are used to cover:
• 03760305400253 - EPIONE RoboKit Plus: 2024-12-16The EPIONE® RoboKit™ Plus is used during the CT guided procedures performed with EPIONE®. Sterile drapes are used to cover: the robotic arm, the touchscreen of the display cart, the tray of the display cart supporting the mouse and the keyboard. Reflective spheres to be placed on the tracked EPIONE instruments tracked. The EPIONE® RoboKit™ Plus includes the accessories individually packaged in their primary packaging considered as sterile, but the EPIONE® RoboKit™ Plus is not sterile.
• 03760305400253 - EPIONE RoboKit Plus: 2024-12-16 The EPIONE® RoboKit™ Plus is used during the CT guided procedures performed with EPIONE®. Sterile drapes are used to cover:
• 03760305400031 - EPIONE: 2023-06-02 The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one
• 03760305400024 - Patient Reference: 2022-09-19 The Patient Reference is an instrument of the EPIONE device used to track the patient position and motions including breathing.
• 03760305400055 - Navigation probe: 2022-09-19 The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in t
• 03760305400062 - Needle Guide: 2022-09-19 The Needle Guide is an instrument of the EPIONE device. It provides mechanical guidance for rigid straight instruments of a rang
• 03760305400079 - Short Navigation Probe: 2022-09-19 The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in t
• 03760305400086 - EPIONE: 2022-09-19 The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one