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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Monarch™ Software Tower v2.1.3 - B634SW0032740201030

Monarch™ Software Tower v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution

  • B634SW0032740201030 ()


  • Robotic surgical system application software

Monarch™ Software Tower v2.1.2 - B634SW0032740201020

Monarch™ Software Tower v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution

  • B634SW0032740201020 ()


  • Robotic surgical system application software

Monarch Advanced Imaging Accessory Kit - B634MON0007090

Window Field Generator, Connection Cable, Mounting System
AURIS HEALTH, INC.
MON-000709
In Commercial Distribution

  • B634MON0007091 ()
  • B634MON0007090 ()
MON-000709

  • Robotic surgical arm system

Monarch Bronchscope 2.0/Monarch Platform (P2) - B634MON0000060

The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator. Monarch Bronchscope 2.0/Monarch Platform (P2)
AURIS HEALTH, INC.
MON-000006
In Commercial Distribution

  • B634MON0000060 ()


  • Robotic surgical arm system

Monarch™ Platform (Refurbished) - B634MON000005R0

The Monarch Platform (Refurbished) enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
AURIS HEALTH, INC.
MON000005R
In Commercial Distribution

  • B634MON000005R0 ()
MON000005R

  • Robotic surgical arm system

Monarch Endoscopy Platform (P1) System, Refurbished - B634MON00000501R0

Monarch Endoscopy Platform (P1) System, Refurbished
AURIS HEALTH, INC.
MON-000005-01R
In Commercial Distribution

  • B634MON00000501R0 ()


  • Robotic surgical arm system

Monarch Endoscopy Platform (P1) Tower Upgrade - B634MON000005010

Monarch Endoscopy Platform (P1) Tower Upgrade
AURIS HEALTH, INC.
MON-000005-01
In Commercial Distribution

  • B634MON000005010 ()


  • Robotic surgical arm system

Monarch Endoscopy Platform (P1) Tower Upgrade - B634MON00000501

Monarch Endoscopy Platform (P1) Tower Upgrade
AURIS HEALTH, INC.
MON-000005-01
Not in Commercial Distribution

  • B634MON00000501 ()


  • Robotic surgical arm system

Monarch™ Platform - B634MON0000050

The Monarch Platform enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
AURIS HEALTH, INC.
MON000005
In Commercial Distribution

  • B634MON0000050 ()
MON000005

  • Robotic surgical arm system

VISICOIL - B887VC110030PL0

1.10mm x 3.0cm VISICOIL loaded in an 17 gauge brachytherapy needle.
Izi Medical Products, LLC
VC-110-030-PL
In Commercial Distribution

  • B887VC110030PL0 ()
VC-110-030-PL

  • Radiological image marker, implantable
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