US Medical Innovations XL-1000CP

GUDID B413XL1000CP0

Canady Helios Cold Plasma Ablation System

US MEDICAL INNOVATIONS, LLC

Electrosurgical system

• Primary Device ID: B413XL1000CP0
• NIH Device Record Key: c79a26e6-475d-4fe0-9278-405f8de3c3c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: US Medical Innovations
• Version Model Number: XL-1000CP
• Catalog Number: XL-1000CP
• Company DUNS: 961656951
• Company Name: US MEDICAL INNOVATIONS, LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B413XL1000CP0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240297

FDA Product Code

• OAB: Low Energy Direct Current Thermal Ablation System

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: 2024-07-02
• Device Publish Date: 2024-06-24

On-Brand Devices [US Medical Innovations]

• B413XL10000: Canady Plasma SMART Electrosurgical Generator
• B413XL1000CP0: Canady Helios Cold Plasma Ablation System