VersaCross Transseptal Sheath

GUDID 00685447003359

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire

Baylis Médicale Cie Inc

Vascular guide-catheter, single-use

• Primary Device ID: 00685447003359
• NIH Device Record Key: a05a86b5-10bb-40ed-a5ca-0525d2473889
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaCross Transseptal Sheath
• Version Model Number: VXS8-35-63-90-D0
• 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: true
• 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
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447003359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183655

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: 2019-07-04
• Device Publish Date: 2019-06-26

On-Brand Devices [VersaCross Transseptal Sheath]

• 00685447003717: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003700: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003694: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003687: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003670: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003663: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003656: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003649: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003632: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003625: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003618: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003601: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003595: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003588: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003571: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003564: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003557: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003540: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003533: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003526: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003519: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003502: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003496: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003489: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003472: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003465: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003458: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003441: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003434: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003427: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003410: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003403: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003397: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003380: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003373: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003366: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003359: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003342: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003335: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
• 00685447003328: 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire