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 New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information 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 device tracking system workstation, mobile A mains electricity (AC-powered) component of an optical surgical navigation device 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 patient with respect to pre-acquired images (e.g., CT or MRI scan), or real-time image data [e.g., ultrasound (US) data].
Regulatory Flags# DUNS number 261610964 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 03701311500445 3DSRW Software L00016 2023-03-01 03701311500995 Broach Set SPX1 A01021 2023-09-04 03701311500971 3D Offset Imaging Set SPX1 A01038 2023-09-04 03701311501015 Navigated Targeting Needle SPX1, Bevel Tip - 11G, 125mm A01020 2023-09-04 03701311501039 Navigated Targeting Needle SPX1, Trocar tip – 11G, 125 mm A01028 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 03701311500322 CoBot I00019 2023-03-01 03701311500407 SURGIVISIO I00001 2023-03-01 03701311501442 Op.n Core Power Cord I01015 2025-11-04 03701311501459 Op.n Core ethernet cable I01016 2025-11-04 03701311501466 Op.n Core HDMI cable I01018 2025-11-04 03701311500032 Broach Set SPX1 A00021 2023-03-01 03701311501497 Op.n ChoiceSpine App L60018 2025-05-15 03701311500018 3D Imaging Set SPX1 A00018 2023-03-01 03701311500391 3D Offset Imaging Set SPX1 A00038 2023-03-01 03701311501275 Op.n Camera I00026 2025-03-20 03701311500865 Op.n Tracker A A00063 2025-03-20 03701311500872 Op.n Tracker B A00064 2025-03-20
Other Devices Sharing Product Codes#