CoBot, Drill Bit

GUDID 03701311500704

ECENTIAL ROBOTICS

Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable

• Primary Device ID: 03701311500704
• NIH Device Record Key: f3ccd525-cd3c-4be9-a79a-df2f77e363f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoBot, Drill Bit
• Version Model Number: A40041
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701311500704 [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

[03701311500704]

Moist Heat or Steam Sterilization

[03701311500704]

Moist Heat or Steam Sterilization

[03701311500704]

Moist Heat or Steam Sterilization

[03701311500704]

Moist Heat or Steam Sterilization

[03701311500704]

Moist Heat or Steam Sterilization

[03701311500704]

Moist Heat or Steam Sterilization

[03701311500704]

Moist Heat or Steam Sterilization

[03701311500704]

Moist Heat or Steam Sterilization

[03701311500704]

Moist Heat or Steam Sterilization

[03701311500704]

Moist Heat or Steam Sterilization

[03701311500704]

Moist Heat or Steam Sterilization

[03701311500704]

Moist Heat or Steam Sterilization

[03701311500704]

Moist Heat or Steam Sterilization

[03701311500704]

Moist Heat or Steam Sterilization

[03701311500704]

Moist Heat or Steam Sterilization

[03701311500704]

Moist Heat or Steam Sterilization

[03701311500704]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-12
• Device Publish Date: 2023-09-04

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
• 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