Numeris Tethered Coagulation System with VisiTrax®

GUDID 00818354015287

5cm Tethered Coagulation System

ATRICURE, INC.

Cardiac radio-frequency ablation system generator

• Primary Device ID: 00818354015287
• NIH Device Record Key: db0224d3-1872-432c-8ec1-65d85d96f021
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Numeris Tethered Coagulation System with VisiTrax®
• Version Model Number: CSK-025
• 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

Device Dimensions

• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354015287 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-10-24

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• 30840143911778 - AtriClip® FLEX-Mini™ LAA Exclusion System: 2024-09-09 LAA Exclusion System, ACHM35
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