Canady Helios Cold Plasma Ablator Handpiece (Handle + 85mm)

GUDID B413CP411100

The Canady Helios Cold Plasma Ablator Handpies (85mm) is an electrosurgical plasma application device that uses and 85mm tip. The device is used to ablate soft tissue.

US MEDICAL INNOVATIONS, LLC

Inert gas-enhanced open-surgery electrosurgical electrode, reusable

• Primary Device ID: B413CP411100
• NIH Device Record Key: 570c5add-3db3-4731-b176-e84e55fcbdf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Canady Helios Cold Plasma Ablator Handpiece (Handle + 85mm)
• Version Model Number: CP-41110
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	B413CP411100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240297

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[B413CP411100]

Ethylene Oxide

[B413CP411100]

Ethylene Oxide

[B413CP411100]

Ethylene Oxide

[B413CP411100]

Ethylene Oxide

[B413CP411100]

Ethylene Oxide

[B413CP411100]

Ethylene Oxide

[B413CP411100]

Ethylene Oxide

[B413CP411100]

Ethylene Oxide

[B413CP411100]

Ethylene Oxide

[B413CP411100]

Ethylene Oxide

[B413CP411100]

Ethylene Oxide

[B413CP411100]

Ethylene Oxide

[B413CP411100]

Ethylene Oxide

[B413CP411100]

Ethylene Oxide

[B413CP411100]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-17
• Device Publish Date: 2024-05-09

Devices Manufactured by US MEDICAL INNOVATIONS, LLC

• B413XL1000CP0 - US Medical Innovations: 2024-07-02 Canady Helios Cold Plasma Ablation System
• B413CP411100 - Canady Helios Cold Plasma Ablator Handpiece (Handle + 85mm): 2024-05-17The Canady Helios Cold Plasma Ablator Handpies (85mm) is an electrosurgical plasma application device that uses and 85mm tip. The device is used to ablate soft tissue.
• B413CP411100 - Canady Helios Cold Plasma Ablator Handpiece (Handle + 85mm): 2024-05-17 The Canady Helios Cold Plasma Ablator Handpies (85mm) is an electrosurgical plasma application device that uses and 85mm tip. T
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• B413AW4225400 - Canady Plasma GIT Side Fire Probe: 2018-07-06 The Canady Hybrid Plasma GIT Side Fire probe is an electrosurgical plasma probe that is 2.3 mm in diameter and 2.3 m long. The e
• B413AW4225410 - Canady Plasma GIT Side Fire Probe: 2018-07-06 The Canady Hybrid Plasma GIT probe is an electrosurgical plasma probe that is 2.3mm in diameter and 3.4m long. The electrosurgic