AuST Steerable Sheath

GUDID 00810024670918

The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

CENTERPOINT SYSTEMS LLC

Vascular guide-catheter, single-use

• Primary Device ID: 00810024670918
• NIH Device Record Key: ffd964a4-3561-4f8c-87ff-8479cc61d7d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AuST Steerable Sheath
• Version Model Number: M85-MD-001466
• Company DUNS: 117126091
• Company Name: CENTERPOINT SYSTEMS LLC
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810024670918 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240829

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: 2024-09-30
• Device Publish Date: 2024-09-20

On-Brand Devices [AuST Steerable Sheath]

• 00810024670925: The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices
• 00810024670918: The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices
• 00810024670901: The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices
• 00810024670895: The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices
• 00810024670888: The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices
• 00810024670673: The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices
• 00810024670666: The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices
• 00810024670659: The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices
• 00810024670642: The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices
• 00810024670635: The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices
• 00810024670628: The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices