Odyssey 001-007010-2

GUDID M58800100701020

The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab

Stereotaxis, Inc.

Cardiac mapping system workstation

• Primary Device ID: M58800100701020
• NIH Device Record Key: 8e9177c2-9a61-483f-8b70-9ca6b3814a5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Odyssey
• Version Model Number: Quad HD
• Catalog Number: 001-007010-2
• Company DUNS: 024942265
• Company Name: Stereotaxis, 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: 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

Customer Support Contacts

• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M58800100701020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072371

FDA Product Code

• DXX: System, Catheter Control, Steerable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-17
• Device Publish Date: 2016-08-01

On-Brand Devices [Odyssey]

• M58800100790010: The Odyssey Workstation is an optional display and user interface package designed to consolidat
• M58800100701020: The Odyssey Workstation is an optional display and user interface package designed to consolidat