Monarch Advanced Imaging Accessory Kit MON-000709

GUDID B634MON0007091

Window Field Generator, Connection Cable, Mounting System

AURIS HEALTH, INC.

Robotic surgical system

• Primary Device ID: B634MON0007091
• NIH Device Record Key: e66064c2-93bf-4afd-9cfc-568c532fe6bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch Advanced Imaging Accessory Kit
• Version Model Number: MON-000709
• Catalog Number: MON-000709
• 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
HIBCC	B634MON0007090 [Primary]
HIBCC	B634MON0007091 [Package]; Contains: B634MON0007090; Package: Box [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: 2021-07-23
• Device Publish Date: 2021-07-15

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