AURIS HEALTH, INC.

AURIS HEALTH, INC.

Address:150 Shoreline Drive,Redwood City,CA,94065,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Bronchoscope (Flexible Or Rigid) (EOQ) (10)

Premarket Exempt

No

Clear

Monarch Bronchoscope - B623MBR000211A0 Catalog Number : MBR-000211-A

Device Description : Monarch Bronchoscope

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Monarch™ Bronchoscope System - B634MBR0000110 Catalog Number : MBR-000011

Device Description : Monarch™ Bronchoscope System

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Aspirating Biopsy Needle - B634MBR0000120 Catalog Number : MBR-000012

Device Description : Aspirating Biopsy Needle

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Biopsy Forceps - Smooth Cup - B634MBR0000140 Catalog Number : MBR-000014

Device Description : Biopsy Forceps - Smooth Cup

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Cytology Brush - B634MBR0000150 Catalog Number : MBR-000015

Device Description : Cytology Brush

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Navigation Patient Patches - B634MBR0000160 Catalog Number : MBR-000016

Device Description : Navigation Patient Patches (Quantity of 60)

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Bronchoscope Patient Introducer Kit - B634MBR0000170 Catalog Number : MBR-000017

Device Description : Bronchoscope Patient Introducer Kit

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Bronchoscope Fluidics Tubing - B634MBR0000180 Catalog Number : MBR-000018

Device Description : Bronchoscope Fluidics Tubing

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Bronchoscope Valve - B634MBR0000190 Catalog Number : MBR-000019

Device Description : Bronchoscope Valve

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Bronchoscope Sheath Valve - B634MBR0000200 Catalog Number : MBR-000020

Device Description : Bronchoscope Sheath Valve

Device Class :

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

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