Monarch™ Software Tower v2.1.5

GUDID B634SW0032740201050

Monarch™ Software Tower v2.1.5

AURIS HEALTH, INC.

Robotic surgical system application software

• Primary Device ID: B634SW0032740201050
• NIH Device Record Key: 0ba4340a-9730-4564-8823-9b03f7233981
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch™ Software Tower v2.1.5
• Version Model Number: Version 2.1.5
• 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: false
• Manufacturing Date: false
• 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
HIBCC	B634SW0032740201050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173760

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: 2019-09-18
• Device Publish Date: 2019-09-10

Devices Manufactured by AURIS HEALTH, INC.

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• 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