Home GUDID 03701311501275 Op.n Camera
Primary DI 03701311501275
Brand Op.n Camera
Company ECENTIAL ROBOTICS
Model I00026
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 03701311501275 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03701311501275 03701311501275 3701311501275
GMDN Terms# Term, Definition table Term Definition Optical surgical navigation/tracking system A mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures; it may be intended to overlay pre-acquired radiological images or real-time data [e.g., ultrasound (US)] for surgical navigation, and be capable of creating digital 3-D patient models. It consists of a workstation with controls/display, position/movement tracking cameras (e.g., infrared), adaptors, and sensors/spatial markers 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., ENT, neurosurgery, CMF surgery].
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 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 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#