VersaCross Steerable Sheath NA

GUDID 00685447005780

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

Baylis Médicale Cie Inc

Vascular guide-catheter, single-use

• Primary Device ID: 00685447005780
• NIH Device Record Key: addf1f68-46af-43a4-9ad4-4619648532c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaCross Steerable Sheath
• Version Model Number: VST85-35-BD-71S-D1
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447005780 [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: 2021-04-16
• Device Publish Date: 2021-04-08

On-Brand Devices [VersaCross Steerable Sheath]

• 00685447004660: 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire
• 00685447004653: 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire
• 00685447004646: 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire
• 00685447005537: 1 x VersaCross Steerable Sheath (including 1 x J-Tip Guidewire); 1 x VersaCross Transseptal Dila
• 00685447005520: 1 x VersaCross Steerable Sheath (including 1 x J-Tip Guidewire); 1 x VersaCross Transseptal Dila
• 00685447005513: 1 x VersaCross Steerable Sheath (including 1 x J-Tip Guidewire); 1 x VersaCross Transseptal Dila
• 00685447005506: 1 x VersaCross Steerable Sheath (including 1 x J-Tip Guidewire); 1 x VersaCross Transseptal Dila
• 00685447005490: 1 x VersaCross Steerable Sheath (including 1 x J-Tip Guidewire); 1 x VersaCross Transseptal Dila
• 00685447005483: 1 x VersaCross Steerable Sheath (including 1 x J-Tip Guidewire); 1 x VersaCross Transseptal Dila
• 00685447005780: 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
• 00685447005773: 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
• 00685447005766: 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
• 00685447005759: 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
• 00685447005742: 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
• 00685447005735: 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
• 00685447010203: 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
• 00685447010197: 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
• 00685447010180: 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
• 00685447010173: 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
• 00685447010166: 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
• 00685447010159: 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator