Op.n Core

GUDID 03701311501435

ECENTIAL ROBOTICS

Optical surgical navigation device tracking system workstation, mobile

• Primary Device ID: 03701311501435
• NIH Device Record Key: 15fe45b7-b4cc-4110-aaad-c55591b8d1d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Op.n Core
• Version Model Number: I01014
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701311501435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242914

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

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: 2025-03-28
• Device Publish Date: 2025-03-20

Devices Manufactured by ECENTIAL ROBOTICS

• 03701311500865 - Op.n Tracker A: 2025-03-28
• 03701311500872 - Op.n Tracker B: 2025-03-28
• 03701311500889 - Op.n Tracker C: 2025-03-28
• 03701311500896 - Op.n Tracker D: 2025-03-28
• 03701311500902 - Navigation Instrument tray: 2025-03-28
• 03701311501275 - Op.n Camera: 2025-03-28
• 03701311501282 - Tracker fixation screw: 2025-03-28
• 03701311501435 - Op.n Core: 2025-03-28
• 03701311501435 - Op.n Core: 2025-03-28