SupraCross Steerable Sheath NA

GUDID 00685447005988

SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire

Baylis Médicale Cie Inc

Vascular guide-catheter, single-use

• Primary Device ID: 00685447005988
• NIH Device Record Key: 2fedb702-05b7-49dc-a2fd-d0e88d2f7198
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SupraCross Steerable Sheath
• Version Model Number: SSS0006
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447005988 [Primary]

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: 2
• Public Version Date: 2023-11-16
• Device Publish Date: 2023-01-25

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