Home GUDID 03701311501121 SURGIVISIO DEVICE
Primary DI 03701311501121
Brand SURGIVISIO DEVICE
Company ECENTIAL ROBOTICS
Model I01001
Published 2023-09-04
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 03701311501121 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03701311501121 03701311501121 3701311501121
GMDN Terms# Term, Definition table Term Definition Mobile general-purpose fluoroscopic x-ray system, digital A mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be both real-time and delayed formats.
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 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 03701311500889 Op.n Tracker C A00065 2025-03-20
Other Devices Sharing Product Codes# 
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