Canady Hybrid Plasma Scalpel

GUDID B413AW4225540

The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 85mm non-bendable tip. The electrosurgical plasma scalpel is used to simultaneously cut and coagulate biological tissue.

US MEDICAL INNOVATIONS, LLC

Argon-enhanced open-surgery electrosurgical electrode

• Primary Device ID: B413AW4225540
• NIH Device Record Key: d33219bf-4f75-4801-b4f4-b3c9360ca088
• Commercial Distribution Discontinuation: 2020-03-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Canady Hybrid Plasma Scalpel
• Version Model Number: AW-422554
• 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	B413AW4225540 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113500

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[B413AW4225540]

Ethylene Oxide

[B413AW4225540]

Ethylene Oxide

[B413AW4225540]

Ethylene Oxide

[B413AW4225540]

Ethylene Oxide

[B413AW4225540]

Ethylene Oxide

[B413AW4225540]

Ethylene Oxide

[B413AW4225540]

Ethylene Oxide

[B413AW4225540]

Ethylene Oxide

[B413AW4225540]

Ethylene Oxide

[B413AW4225540]

Ethylene Oxide

[B413AW4225540]

Ethylene Oxide

[B413AW4225540]

Ethylene Oxide

[B413AW4225540]

Ethylene Oxide

[B413AW4225540]

Ethylene Oxide

[B413AW4225540]

Ethylene Oxide

[B413AW4225540]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-23
• Device Publish Date: 2018-03-05

On-Brand Devices [Canady Hybrid Plasma Scalpel]

• B413AW4225540: The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 85mm non-bend
• B413AW4225520: The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 35mm non-bend