XR-MX/1000 29255

GUDID 07630039101046

The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimally invasive urological surgery). The system may be used for urological treatment, planning and diagnostic procedures.

Storz Medical AG

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• Primary Device ID: 07630039101046
• NIH Device Record Key: 6be43fe0-67f1-453c-a998-69c6db6f2165
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XR-MX/1000
• Version Model Number: FD43 (80 kW)
• Catalog Number: 29255
• Company DUNS: 481967776
• Company Name: Storz Medical AG
• Device Count: 1
• DM Exempt: true
• 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	07630039101046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200965

FDA Product Code

• JAA: System, X-Ray, Fluoroscopic, Image-Intensified

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: 2021-04-16
• Device Publish Date: 2021-04-08

On-Brand Devices [XR-MX/1000]

• 07630039101084: The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urologi
• 07630039101053: The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urologi
• 07630039101046: The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urologi