Microwave Ablation Generator

GUDID 06954414674453

Microwave Ablation Generator

Canyon Medical Inc.

Microwave hyperthermia system

• Primary Device ID: 06954414674453
• NIH Device Record Key: e500f9d5-0764-4000-904a-7dbe1e6ca049
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microwave Ablation Generator
• Version Model Number: KY-2100A
• Company DUNS: 527310648
• Company Name: Canyon Medical 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: true
• 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	06954414674453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241827

FDA Product Code

• NEY: System, Ablation, Microwave And Accessories

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: 2025-03-24
• Device Publish Date: 2025-03-14

On-Brand Devices [Microwave Ablation Generator]

• 06954414674453: Microwave Ablation Generator
• 06954414610024: Microwave Ablation Generator