AtriCure Isolator Synergy EnCompass Clamp and Guide System A001143

GUDID 10840143904110

Surgical Ablation System Open, Long Jaw with Glidepath Magnetic Guide

ATRICURE, INC.

Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator

• Primary Device ID: 10840143904110
• NIH Device Record Key: 7638a44d-f9f7-400a-86db-4effaf575673
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AtriCure Isolator Synergy EnCompass Clamp and Guide System
• Version Model Number: OLH
• Catalog Number: A001143
• 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: 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: true
• RX Perscription: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840143904110 [Primary]
GS1	30840143903353 [Package]; Package: Box [1 Units]; In Commercial Distribution
GS1	50840143900066 [Package]; Contains: 30840143903353; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210477

FDA Product Code

• OCL: Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-06
• Device Publish Date: 2021-07-29

On-Brand Devices [AtriCure Isolator Synergy EnCompass Clamp and Guide System]

• 10840143904127: Surgical Ablation System Open, Standard Jaw with Glidepath Magnetic Guide
• 10840143904110: Surgical Ablation System Open, Long Jaw with Glidepath Magnetic Guide
• 10840143905520: Glidepath Magnetic Guide
• 10840143905209: Surgical Ablation System Open, Standard Jaw with Glidepath Magnetic Guide
• 30840143904817: Surgical Ablation System Open, Standard Jaw with Glidepath Magnetic Guide