SupraCross Steerable Sheath

GUDID 00685447002574

SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire

Baylis Médicale Cie Inc

Vascular guide-catheter, single-use

• Primary Device ID: 00685447002574
• NIH Device Record Key: 6585af9c-76dd-4a50-b1a1-739fa925b36a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SupraCross Steerable Sheath
• Version Model Number: SSS85-35-UD-45XL
• 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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447002574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122926

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-23
• Device Publish Date: 2018-09-20

On-Brand Devices [SupraCross Steerable Sheath]

• 00685447002574: SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447002567: SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447002550: SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447001669: SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447001270: SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447005629: SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447005612: SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447005605: SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447005988: SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447005971: SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447005964: SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire