VersaCross Transseptal Dilator

GUDID 00685447004684

Baylis Médicale Cie Inc

Cardiac transseptal dilator

• Primary Device ID: 00685447004684
• NIH Device Record Key: 98f9bc87-28dc-46f6-baa9-c172c7f2755c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaCross Transseptal Dilator
• Version Model Number: VCD85-35-95-D1
• 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
• 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
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com

Device Dimensions

• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Length: 95 Centimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447004684 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190688

FDA Product Code

• DYB: Introducer, 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: 2019-10-01
• Device Publish Date: 2019-09-23

On-Brand Devices [VersaCross Transseptal Dilator]

• 00685447004684: VCD85-35-95-D1
• 00685447004677: VCD85-35-95-D0