Monarch Bronchscope 2.0/Monarch Platform (P2), Refurbished

GUDID 20810068810893

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), refurbished.

AURIS HEALTH, INC.

Robotic surgical arm system

• Primary Device ID: 20810068810893
• NIH Device Record Key: a9c30270-1900-4261-bec9-afb6e164a200
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch Bronchscope 2.0/Monarch Platform (P2), Refurbished
• Version Model Number: MON-000006-RFB
• Company DUNS: 015823456
• Company Name: AURIS HEALTH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10810068810896 [Primary]
GS1	20810068810893 [Package]; Contains: 10810068810896; Package: Crate [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211493

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-12
• Device Publish Date: 2025-08-04

Devices Manufactured by AURIS HEALTH, INC.

• 20810068810893 - Monarch Bronchscope 2.0/Monarch Platform (P2), Refurbished: 2025-08-12The 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), refurbished.
• 20810068810893 - Monarch Bronchscope 2.0/Monarch Platform (P2), Refurbished: 2025-08-12 The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) unde
• 20810068811166 - Monarch Platform, Bronchoscopy 4.1, Refurbished: 2025-08-12 The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) unde
• 10810068811497 - Monarch™ Tower Software v4.1.1: 2025-06-12 Monarch™ Tower Software v4.1.1
• 10810068811503 - Monarch™ Cart Software v4.1.1: 2025-06-12 Monarch™ Cart Software v4.1.1
• 10810068811510 - Monarch™ Laptop P17 Software v4.1.1: 2025-06-12 Monarch™ Laptop P17 Software v4.1.1
• 10810068811527 - Monarch™ Laptop P16 Software v4.1.1: 2025-06-12 Monarch™ Laptop P16 Software v4.1.1
• 10810068810971 - Monarch Endoscopy Controller: 2025-03-13 Monarch Endoscopy Controller
• 10810068810582 - Monarch™ Tower Software v4.1.0: 2025-03-11 Monarch™ Tower Software v4.1.0