Home GUDID B634MON0007091 Monarch Advanced Imaging Accessory Kit
Primary DI B634MON0007091
Brand Monarch Advanced Imaging Accessory Kit
Company AURIS HEALTH, INC.
Model MON-000709
Catalog number MON-000709
Device description Window Field Generator, Connection Cable, Mounting System
Published 2021-07-15
Public version status New
Distribution status 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 EOQ Bronchoscope (Flexible Or Rigid)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B634MON0007091 Package HIBCC 1 In Commercial Distribution B634MON0007090 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Robotic surgical system An assembly of electromechanical devices typically used during orthopaedic computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of, e.g., an operator console and arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.
Regulatory Flags# DUNS number 015823456 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 10810068810940 MONARCH™ Advanced Imaging Accessory Kit MON-000709 MON-000709 2026-06-02 10810068810841 MONARCH™ Navigation Sensors MON-000705 MON-000705 2026-05-27 10810068810988 Monarch Platform, Bronchoscopy MON-000008 2025-03-03 10810068810858 MONARCH™ Controller MON-000706 MON-000706 2026-05-27 10810068811046 MONARCH™Platform, Urology MON-000007 MON-000007 2026-05-05 10810068811053 Monarch® Ureteroscopy Kit MUR-000011 MUR-000011 2026-05-05 10810068811077 Monarch®Platform Drape Kit MUR-000013 MUR-000013 2026-05-05 10810068811084 MONARCH™ Kit Catheter & Accessories MUR-000014 MUR-000014 2026-05-05 10810068811114 MONARCH™ Mini-PCNL Suction Set MUR-000017 MUR-000017 2026-05-05 10810068811060 MONARCH™Guided Percutaneous Access Kit MUR-000012 MUR-000012 2026-05-04 10810068811091 MONARCH™ Stone Retrieval Basket MUR-000015 MUR-000015 2026-05-04 10810068811107 MONARCH™ Urology Irrigation Cartridge MUR-000016 MUR-000016 2026-05-04 10810068811121 MONARCH™ Ureteroscope Valve MUR-000026 MUR-000026 2026-05-04 10810068811138 MONARCH™ Bronchoscope MBR-000211-B MBR-000211-B 2026-04-21 10810068810896 Monarch Bronchscope 2.0/Monarch Platform (P2), Refurbished MON-000006-RFB 2025-08-04 10810068811169 Monarch Platform, Bronchoscopy 4.1, Refurbished MON-000008-RFB 2025-08-04 B634MON0007090 Monarch Advanced Imaging Accessory Kit MON-000709 MON-000709 2021-07-15 10810068810803 Monarch Bronchscope 2.0/Monarch Platform (P2) MON-000006 2024-05-05 B634MON00000501R0 Monarch Endoscopy Platform (P1) System, Refurbished MON-000005-01R 2020-03-25 B634MON000005010 Monarch Endoscopy Platform (P1) Tower Upgrade MON-000005-01 2020-07-13
Other Devices Sharing Product Codes#