Evident VT2220

GUDID 10884524002538

MWA Percutaneous Antenna

Covidien LP

Microwave hyperthermia system applicator, intracorporeal

• Primary Device ID: 10884524002538
• NIH Device Record Key: e58c7513-1adb-425b-8815-73a516cf3a83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evident
• Version Model Number: VT2220
• Catalog Number: VT2220
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: false
• 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

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884524002538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011676

FDA Product Code

• NEY: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-22
• Device Publish Date: 2016-09-24

On-Brand Devices [Evident]

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• 10884524002286: MWA Percutaneous Antenna
• 10884524002521: MWA Percutaneous Antenna
• 10884524001722: MWA Cart
• 10884524000671: MWA Percutaneous Antenna
• 10884524000336: MWA Percutaneous Antenna
• 10884524000688: MWA Percutaneous Antenna
• 10884524002583: MWA Surgical Antenna
• 10884524001579: MWA Generator