Monarch Bronchscope 2.0/Monarch Platform (P2)

GUDID 10810068810803

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.

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• Primary Device ID: 10810068810803
• NIH Device Record Key: c51b430a-4f56-4bb0-af7c-1b3b03a138e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch Bronchscope 2.0/Monarch Platform (P2)
• Version Model Number: MON-000006
• 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	10810068810803 [Primary]
GS1	20810068810800 [Package]; 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: 2024-05-13
• Device Publish Date: 2024-05-05

On-Brand Devices [Monarch Bronchscope 2.0/Monarch Platform (P2)]

• B634MON0000060: The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexib
• 10810068810803: The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexib