Synergy™ Ablation System A000435

GUDID 30840143903018

AtriCure Switch Box

ATRICURE, INC.

Electrosurgical cable adaptor

• Primary Device ID: 30840143903018
• NIH Device Record Key: ffd3eb7c-c397-4f13-b10e-661c98dc70e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synergy™ Ablation System
• Version Model Number: ASB3
• Catalog Number: A000435
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354010596 [Previous]
GS1	10840143901584 [Primary]
GS1	30840143903018 [Package]; Contains: 10840143901584; Package: box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100046

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: 2021-01-19
• Device Publish Date: 2021-01-11

On-Brand Devices [Synergy™ Ablation System]

• 00818354016291: Glidepath Tape (1-Unit)
• 00818354010718: Glidepath Tape (3-Unit)
• 00818354010596: AtriCure Switch Box
• 00818354010558: Isolator Synergy™ Surgical Ablation System Open, Short Jaw, Left Curve
• 00818354010503: Isolator Synergy™ Surgical Ablation System Open, Long Jaw, Left Curve
• 00818354010206: Ablation and Sensing Unit
• 00818354010312: Footswitch ASU2/ASU3
• 30840143902318: Isolator Synergy™ Surgical Ablation System Open, Short Jaw, Left Curve
• 30840143902141: Isolator Synergy™ Surgical Ablation System Open, Long Jaw, Left Curve
• 30840143903018: AtriCure Switch Box
• 30840143901625: Glidepath Tape (3-Unit)