Home GUDID 03701311501435 Op.n Core
Primary DI 03701311501435
Brand Op.n Core
Company ECENTIAL ROBOTICS
Model I01014
Published 2025-03-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name OLO Orthopedic Stereotaxic Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OLO Orthopedic Stereotaxic Instrument Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03701311501435 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03701311501435 03701311501435 3701311501435
GMDN Terms# Term, Definition table Term Definition Optical surgical navigation/tracking system workstation, mobile An electrically-powered component of an optical surgical navigation and/or tracking system intended to act as the user interface for controlling the function of the system during computer assisted surgery (CAS). It consists of a mobile (on wheels) computer unit with an image display screen, a mobile infrared (IR) light camera, and integrated software; it may be a stand-alone unit or integrated into an endoscopic video tower or surgical pendant. The system provides an optical tool for the tracking of instruments and the patient, and may be intended to facilitate overlay of pre-acquired images [e.g., computed tomography (CT)] or real-time image data [e.g., ultrasound (US)].
Regulatory Flags# DUNS number 261610964 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 03701311500865 Op.n Tracker A A00063 2025-03-20 03701311500872 Op.n Tracker B A00064 2025-03-20 03701311500889 Op.n Tracker C A00065 2025-03-20 03701311500896 Op.n Tracker D A00066 2025-03-20 03701311501275 Op.n Camera I00026 2025-03-20 03701311501282 Tracker fixation screw A00075 2025-03-20 03701311501374 Patient Tracker SPX1 A01039 2023-12-15 03701311500940 3D Imaging Set SPX1 A01018 2023-09-06 03701311500742 Fixation screw A40047 2023-09-04 03701311500759 CoBot, Tool Holder A40044 2023-09-04 03701311500773 Robotic, Tool Holder – Tracker A40059 2023-09-04 03701311500971 3D Offset Imaging Set SPX1 A01038 2023-09-04 03701311501053 Navigation set SPX1, Targeting Needle SPX1, Bevel Tip - 11G, 125 mm A01019 2023-09-04 03701311501077 Navigation set SPX1, Targeting Needle SPX1, Trocar Tip - 11G, 125 mm A01029 2023-09-04 03701311501121 SURGIVISIO DEVICE I01001 2023-09-04 03701311500285 Robotic, Tool Holder - Fixation Screw A40007 2023-03-02 03701311500018 3D Imaging Set SPX1 A00018 2023-03-01 03701311500070 Navigation Set SPX1, Targeting Needle Bevel Tip - 11G, 125mm A00019 2023-03-01 03701311500230 Robotic, Tool Holder Dia. 6 mm A40004 2023-03-01 03701311500308 Robotic, Tool Holder - Tracker A40013 2023-03-01
Other Devices Sharing Product Codes#