SureFlex Steerable Guiding Sheath NA

GUDID 00685447005797

SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire

Baylis Médicale Cie Inc

Vascular guide-catheter, single-use

• Primary Device ID: 00685447005797
• NIH Device Record Key: 5b28a5eb-c0c4-4ba4-b9d2-89ff243c1180
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureFlex Steerable Guiding Sheath
• Version Model Number: TSK85-32-BD-71S
• 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
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• Email: info@baylismedical.com
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• 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	00685447005797 [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: 2021-04-20
• Device Publish Date: 2021-04-12

On-Brand Devices [SureFlex Steerable Guiding Sheath]

• 00685447001706: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447001690: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447001683: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447001676: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000860: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000853: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000846: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447000839: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447004622: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447004615: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447004608: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447005810: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447005803: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447005797: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447005667: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447005650: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447005643: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447010470: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447010463: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447010456: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447006329: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447006312: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447006305: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447006237: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447006220: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447006213: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire