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
OTC false
Sterile false
Single use false 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 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 03701311501435 Op.n Core I01014 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 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# 
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