VersaCross Connect LAAC Access Solution NA

GUDID 00685447012610

1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))

Baylis Médicale Cie Inc

Cardiac transseptal access set

• Primary Device ID: 00685447012610
• NIH Device Record Key: b83d555c-9619-4a55-81c7-19e0134697bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaCross Connect LAAC Access Solution
• Version Model Number: VXAK0011
• Catalog Number: NA
• 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
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• Email: info@baylismedical.com

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447012610 [Primary]

FDA Product Code

• DRE: Dilator, Vessel, For Percutaneous Catheterization

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: 2022-08-22
• Device Publish Date: 2022-08-12

On-Brand Devices [VersaCross Connect LAAC Access Solution]

• 00685447010579: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447010562: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447010555: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447010548: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447010524: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447010517: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447010500: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447010494: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447018407: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447018391: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447018384: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447018377: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447018360: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447018353: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447018346: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447018339: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447012634: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447012627: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447012610: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447012603: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447012597: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447012580: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447012573: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
• 00685447012566: 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa