EPi-Sense Guided Coagulation System with VisiTrax CDK-1413-3

GUDID 10840143904554

3 cm Guided Coagulation System Kit

ATRICURE, INC.

Cardiac radio-frequency ablation system generator

• Primary Device ID: 10840143904554
• NIH Device Record Key: 1239ebde-ff20-4167-a932-e28f30532c9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPi-Sense Guided Coagulation System with VisiTrax
• Version Model Number: CDK-1413
• Catalog Number: CDK-1413-3
• 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: false
• 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
• 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
• 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
• 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

Device Dimensions

• Length: 3 Centimeter
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10840143904554 [Primary]
GS1	30840143903827 [Package]; Package: box [1 Units]; In Commercial Distribution
GS1	50840143903364 [Package]; Contains: 30840143903827; Package: case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120857

FDA Product Code

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

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: 2021-06-01
• Device Publish Date: 2021-05-24

On-Brand Devices [EPi-Sense Guided Coagulation System with VisiTrax]

• 00818354015300: RF Coagulation Cable Kit
• 00818354015249: 3cm Guided Coagulation System Kit
• 00818354015201: 1cm Guided Coagulation System Kit
• 30840143900352: RF Coagulation Cable Kit
• 30840143900338: 3cm Guided Coagulation System Kit
• 10840143904554: 3 cm Guided Coagulation System Kit