FindrWIRZ 4005

GUDID 00818354017588

FindrWIRZ Guidewire System

ATRICURE, INC.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00818354017588
• NIH Device Record Key: 619bdd78-fcee-4ca9-9900-9874515942cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FindrWIRZ
• Version Model Number: 4005
• Catalog Number: 4005
• 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: 650-354-1200
• Email: info@sentreheart.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354017588 [Primary]
HIBCC	M95540050 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080364

FDA Product Code

• DQX: Wire, Guide, Catheter

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: 2019-12-31
• Device Publish Date: 2019-12-23

On-Brand Devices [FindrWIRZ ]

• 00818354017588: FindrWIRZ Guidewire System
• 10840143901751: FindrWIRZ Guide Wire System
• 30840143909522: FindrWIRZ Guide Wire System