Multifunctional Ablation Generator A001372

GUDID 10840143900044

The MAG is an electro-mechanical ablation system that utilizes both monopolar and bipolar radio frequency (RF) energy to ablate biological tissue. The MAG can be used with a variety of AtriCure Handpieces to perform cardiac ablations.

ATRICURE, INC.

Cardiac radio-frequency ablation system generator

• Primary Device ID: 10840143900044
• NIH Device Record Key: 6e5799c0-7436-48a2-b591-ffd6e213b6f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multifunctional Ablation Generator
• Version Model Number: MAG
• Catalog Number: A001372
• Company DUNS: 006133784
• Company Name: ATRICURE, INC.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Temperature between -29 to 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transit Humidity between 30% to 85% relative humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840143900044 [Direct Marking]
GS1	30840143904473 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221358

FDA Product Code

• OCM: Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-01
• Device Publish Date: 2023-02-21

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