Robotic, Tool Holder - Fixation Screw

GUDID 03701311500285

ECENTIAL ROBOTICS

Intraoperative optical-tracking spatial register connector

• Primary Device ID: 03701311500285
• NIH Device Record Key: c214d1ab-73e0-4329-b7d0-3eb5851b3891
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Robotic, Tool Holder - Fixation Screw
• Version Model Number: A40007
• Company DUNS: 261610964
• Company Name: ECENTIAL ROBOTICS
• 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: true
• Serial Number: false
• 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: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701311500285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221028

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[03701311500285]

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[03701311500285]

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[03701311500285]

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[03701311500285]

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[03701311500285]

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[03701311500285]

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[03701311500285]

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[03701311500285]

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[03701311500285]

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[03701311500285]

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[03701311500285]

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[03701311500285]

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[03701311500285]

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-10
• Device Publish Date: 2023-03-02

Devices Manufactured by ECENTIAL ROBOTICS

• 03701311501374 - Patient Tracker SPX1: 2023-12-25
• 03701311500940 - 3D Imaging Set SPX1: 2023-09-14
• 03701311500704 - CoBot, Drill Bit: 2023-09-12
• 03701311500711 - CoBot, Drill Guide – Sleeve: 2023-09-12
• 03701311500728 - CoBot, Drill Guide – Cortical tip: 2023-09-12
• 03701311500735 - 3.5 mm Hex Head Screwdriver: 2023-09-12
• 03701311500742 - Fixation screw: 2023-09-12
• 03701311500759 - CoBot, Tool Holder: 2023-09-12