Home GUDID 03701311500872 Op.n Tracker B
Primary DI 03701311500872
Brand Op.n Tracker B
Company ECENTIAL ROBOTICS
Model A00064
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 03701311500872 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03701311500872 03701311500872 3701311500872
GMDN Terms# Term, Definition table Term Definition Surgical optical-tracking spatial marker, reusable A non-powered, noninvasive component of a surgical navigation and/or device tracking system (e.g., computer-assisted surgical ultrasound system, surgical microscope) intended for preoperative and/or intraoperative use to function as an optical reference to enable spatial registration/tracking of the position/movement/size of a patient, another marker, and/or surgical instrument (e.g., stereotactic surgery probe). It may be attached to the patient, another marker or surgical instrument, and may contain features (e.g., reflective spheres, contrast patterns) detectable by a tracking camera. Procedural supportive devices (e.g., drapes) may be included with the device. This is a reusable device.
Sterilization Methods# Method table Method Dry Heat Sterilization
Regulatory Flags# DUNS number 261610964 Device count 1 Lot or batch true Sterilization required before use 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 03701311500889 Op.n Tracker C A00065 2025-03-20
Other Devices Sharing Product Codes#