Canady Hybrid Plasma Paddle Blade

GUDID B413PB4225550

The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 85mm bendable paddle blade tip. The electrosurgical plasma scalpel

US MEDICAL INNOVATIONS, LLC

Argon-enhanced open-surgery electrosurgical electrode

• Primary Device ID: B413PB4225550
• NIH Device Record Key: 6e825663-7f43-447e-be16-997792b6633f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Canady Hybrid Plasma Paddle Blade
• Version Model Number: PB-422555
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B413PB4225550 [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

[B413PB4225550]

Ethylene Oxide

[B413PB4225550]

Ethylene Oxide

[B413PB4225550]

Ethylene Oxide

[B413PB4225550]

Ethylene Oxide

[B413PB4225550]

Ethylene Oxide

[B413PB4225550]

Ethylene Oxide

[B413PB4225550]

Ethylene Oxide

[B413PB4225550]

Ethylene Oxide

[B413PB4225550]

Ethylene Oxide

[B413PB4225550]

Ethylene Oxide

[B413PB4225550]

Ethylene Oxide

[B413PB4225550]

Ethylene Oxide

[B413PB4225550]

Ethylene Oxide

[B413PB4225550]

Ethylene Oxide

[B413PB4225550]

Ethylene Oxide

[B413PB4225550]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-05

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