Bronchoscope Sheath Valve

FDA UDI

AURIS HEALTH, INC.·B634MBR0000200·Bronchoscope Sheath Valve

Monarch Software Tower v2.2.1

FDA UDI

AURIS HEALTH, INC.·B634SW0121920202000·Monarch Software Tower v2.2.1

Monarch™ Bronchoscope System

FDA UDI

AURIS HEALTH, INC.·B634MBR0000110·Monarch™ Bronchoscope System

Monarch Endoscopy Platform (P1) System, Refurbished

FDA UDI

AURIS HEALTH, INC.·B634MON00000501R0·Monarch Endoscopy Platform (P1) System, Refurbi...

Monarch Software Cart v2.1.6

FDA UDI

AURIS HEALTH, INC.·B634SW0121890201060·Monarch Software Cart v2.1.6

Monarch™ Software Cart v2.1.4

FDA UDI

AURIS HEALTH, INC.·B634SW0032750201040·Monarch™ Software Cart v2.1.4

Monarch Software Laptop v2.1.6

FDA UDI

AURIS HEALTH, INC.·B634SW0121900201060·Monarch Software Laptop v2.1.6

Monarch Bronchscope 2.0/Monarch Platform (P2)

FDA UDI

AURIS HEALTH, INC.·B634MON0000060·The Monarch Bronchoscope enables electro-mechan...

Bronchoscope Fluidics Tubing

FDA UDI

AURIS HEALTH, INC.·B634MBR0000180·Bronchoscope Fluidics Tubing

Bronchoscope Patient Introducer Kit

FDA UDI

AURIS HEALTH, INC.·B634MBR0000170·Bronchoscope Patient Introducer Kit

Biopsy Forceps - Smooth Cup

FDA UDI

AURIS HEALTH, INC.·B634MBR0000140·Biopsy Forceps - Smooth Cup

Monarch Software Tower v2.1.6

FDA UDI

AURIS HEALTH, INC.·B634SW0121880201060·Monarch Software Tower v2.1.6

Monarch™ Software Laptop v2.1.5

FDA UDI

AURIS HEALTH, INC.·B634SW0032760201050·Monarch™ Software Laptop v2.1.5

Navigation Patient Patches

FDA UDI

AURIS HEALTH, INC.·B634MBR0000160·Navigation Patient Patches (Quantity of 60)

Monarch Bronchoscope

FDA UDI

AURIS HEALTH, INC.·B634MBR000211A0·

Monarch Software Cart v2.2.1

FDA UDI

AURIS HEALTH, INC.·B634SW0121930202000·Monarch Software Cart v2.2.1

Monarch Endoscopy Platform (Monarch Platform)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Auris Robotic Endoscopy System (ARES)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NET-2000 MICROCURRENT STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

Monarch Bronchoscope

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat