EPstar Fixed Electrophysiology Catheter

GUDID 00685447003748

8 electrodes; Electrode spacing: 5-5-5 mm

Baylis Médicale Cie Inc

Cardiac mapping catheter, percutaneous, single-use

• Primary Device ID: 00685447003748
• NIH Device Record Key: 005d2954-8a13-4f25-b5e2-785befad6f1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPstar Fixed Electrophysiology Catheter
• Version Model Number: DCF-2-8-55-130
• Company DUNS: 249225954
• Company Name: Baylis Médicale Cie 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: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com

Device Dimensions

• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French
• Length: 130 Centimeter
• Catheter Gauge: 2 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447003748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183649

FDA Product Code

• DRF: Catheter, Electrode Recording, Or Probe, Electrode Recording

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: 2019-09-09
• Device Publish Date: 2019-08-30

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