Needle Guide 02-0027-19G

GUDID 03760305400062

The Needle Guide is an instrument of the EPIONE device. It provides mechanical guidance for rigid straight instruments of a range of external diameter specified in the Technical Specifications.

QUANTUM SURGICAL

Robotic surgical navigation system

• Primary Device ID: 03760305400062
• NIH Device Record Key: bbfc7dc1-5bbf-4631-8e39-b23a918afca4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Needle Guide
• Version Model Number: 02-0027
• Catalog Number: 02-0027-19G
• Company DUNS: 268397609
• Company Name: QUANTUM SURGICAL
• Device Count: 1
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760305400062 [Primary]

FDA Product Code

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

Sterilization

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

[03760305400062]

Moist Heat or Steam Sterilization

[03760305400062]

Moist Heat or Steam Sterilization

[03760305400062]

Moist Heat or Steam Sterilization

[03760305400062]

Moist Heat or Steam Sterilization

[03760305400062]

Moist Heat or Steam Sterilization

[03760305400062]

Moist Heat or Steam Sterilization

[03760305400062]

Moist Heat or Steam Sterilization

[03760305400062]

Moist Heat or Steam Sterilization

[03760305400062]

Moist Heat or Steam Sterilization

[03760305400062]

Moist Heat or Steam Sterilization

[03760305400062]

Moist Heat or Steam Sterilization

[03760305400062]

Moist Heat or Steam Sterilization

[03760305400062]

Moist Heat or Steam Sterilization

[03760305400062]

Moist Heat or Steam Sterilization

[03760305400062]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-19
• Device Publish Date: 2022-09-09

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: 2024-12-16 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: 2022-09-19The Needle Guide is an instrument of the EPIONE device. It provides mechanical guidance for rigid straight instruments of a range of external diameter specified in the Technical Specifications.
• 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