VersaCross Large Access Solution NA

GUDID 00685447006886

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 Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set

• Primary Device ID: 00685447006886
• NIH Device Record Key: 03f82c8c-0df1-4bc1-b97d-4beec24f6f44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaCross Large Access Solution
• Version Model Number: VLAK0011
• 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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447006886 [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