SynchroWave Antenna Kit SW-1415

GUDID 00851551005064

15cm Long Tip Antenna and Cooling Circuit

PERSEON CORPORATION

Microwave ablation system probe Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered

• Primary Device ID: 00851551005064
• NIH Device Record Key: 16212b4d-e9bf-4eb7-a09f-fa2fbc1e96cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SynchroWave Antenna Kit
• Version Model Number: SW-1415
• Catalog Number: SW-1415
• Company DUNS: 080414615
• Company Name: PERSEON CORPORATION
• 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: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com
• Phone: 801-972-5555
• Email: support@perseonmedical.com

Device Dimensions

• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851551005064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141785

FDA Product Code

• NEY: System, Ablation, Microwave And Accessories

Sterilization

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

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

[00851551005064]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-09
• Device Publish Date: 2017-08-19

On-Brand Devices [SynchroWave Antenna Kit]

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• 00851551005088: 15cm Short Tip Antenna and Cooling Circuit
• 00851551005071: 20cm Long Tip Antenna and Cooling Circuit
• 00851551005064: 15cm Long Tip Antenna and Cooling Circuit