Home GUDID 03701311500407 SURGIVISIO
Primary DI 03701311500407
Brand SURGIVISIO
Company ECENTIAL ROBOTICS
Model I00001
Published 2023-03-01
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name JAA System, X-Ray, Fluoroscopic, Image-Intensified OLO Orthopedic Stereotaxic Instrument OWB Interventional Fluoroscopic X-Ray System OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology 2 OLO Orthopedic Stereotaxic Instrument Neurology 2 OWB Interventional Fluoroscopic X-Ray System Radiology 2 OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03701311500407 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03701311500407 03701311500407 3701311500407
GMDN Terms# Term, Definition table Term Definition Optical surgical navigation device tracking system A mobile assembly of mains electricity (AC-powered) devices intended to provide a physician with optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, a position/movement tracking camera, adaptors, and sensors/localizers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ear/nose/throat (ENT), neurosurgical, or craniomaxillofacial (CMF) surgery].
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 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 03701311500889 Op.n Tracker C A00065 2025-03-20
Other Devices Sharing Product Codes# 
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