Home GUDID 03701311500445 3DSRW Software
Primary DI 03701311500445
Brand 3DSRW Software
Company ECENTIAL ROBOTICS
Model L00016
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
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 03701311500445 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03701311500445 03701311500445 3701311500445
GMDN Terms# Term, Definition table Term Definition Robotic surgical navigation system application software An individual application software program or group of programs, routines and/or algorithms designed for use in association with a robotic surgical navigation system used in computer assisted surgery (CAS) so that this can function according to its intended purpose. This program can be permanently installed or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.
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 false 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 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 03701311500872 Op.n Tracker B A00064 2025-03-20 03701311500889 Op.n Tracker C A00065 2025-03-20
Other Devices Sharing Product Codes# 
ecential-robotics.com