TorFlex Transseptal Guiding Sheath

GUDID 00685447005322

TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire

Baylis Médicale Cie Inc

Vascular guide-catheter, single-use

• Primary Device ID: 00685447005322
• NIH Device Record Key: 8d86271d-ded7-4f36-a9a0-9892d1f967e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TorFlex Transseptal Guiding Sheath
• Version Model Number: TF8-32-63-135
• 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
• 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	00685447005322 [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: 2021-11-09
• Device Publish Date: 2021-11-01

On-Brand Devices [TorFlex Transseptal Guiding Sheath]

• 00685447003199: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003106: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003090: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447001645: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447001638: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447001621: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447001614: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000822: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000815: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000808: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000792: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000785: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000778: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000761: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000754: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000747: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000730: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000723: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000716: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000709: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000693: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000686: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000679: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000662: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000655: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000648: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000631: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003953: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003946: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003939: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003922: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003915: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003908: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003892: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003885: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003878: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003861: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003854: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003847: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003830: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003823: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003816: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003809: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003793: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003786: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003779: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447003762: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447006169: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447006152: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447005476: TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire