VersaCross Large Access Solution NA

GUDID 00685447006930

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

Baylis Médicale Cie Inc

Cardiac transseptal access set

• Primary Device ID: 00685447006930
• NIH Device Record Key: 224be256-0e56-4955-87f9-ce0b18f2e063
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaCross Large Access Solution
• Version Model Number: VLAK0016
• 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
• 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
• 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
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447006930 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150709

FDA Product Code

• DXF: Catheter, Septostomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-02
• Device Publish Date: 2021-07-23

On-Brand Devices [VersaCross Large Access Solution]

• 00685447006916: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447006909: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447006879: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447006862: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447006831: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447006824: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447006794: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447006787: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447006930: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447006923: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447006893: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447006886: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447006855: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447006848: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447006817: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447006800: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447012559: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447012542: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447012535: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447012528: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447012511: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447012504: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447012498: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447012481: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447012474: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447012467: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447012450: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447012443: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447012436: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447012429: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447012412: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447012405: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447017592: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447017585: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447017578: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447017561: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447017554: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447017547: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447017530: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447017523: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447017516: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447017509: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447017493: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447017486: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447017479: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447017462: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447017455: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
• 00685447017448: 1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x