GORE GDSF2433

GUDID 00733132659036

DrySeal Hydro Flex Sheath Ao 33cmx24Fr

W. L. Gore & Associates, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00733132659036
• NIH Device Record Key: 731ae448-4562-4a65-aabe-f2c07b190ed7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE
• Version Model Number: GDSF2433
• Catalog Number: GDSF2433
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Length: 39 Centimeter
• Catheter Gauge: 24 French
• Lumen/Inner Diameter: 8 Millimeter
• Length: 39 Centimeter
• Catheter Gauge: 24 French
• Lumen/Inner Diameter: 8 Millimeter
• Length: 39 Centimeter
• Catheter Gauge: 24 French
• Lumen/Inner Diameter: 8 Millimeter
• Length: 39 Centimeter
• Catheter Gauge: 24 French
• Lumen/Inner Diameter: 8 Millimeter
• Length: 39 Centimeter
• Catheter Gauge: 24 French
• Lumen/Inner Diameter: 8 Millimeter
• Length: 39 Centimeter
• Catheter Gauge: 24 French
• Lumen/Inner Diameter: 8 Millimeter
• Length: 39 Centimeter
• Catheter Gauge: 24 French
• Lumen/Inner Diameter: 8 Millimeter
• Length: 39 Centimeter
• Catheter Gauge: 24 French
• Lumen/Inner Diameter: 8 Millimeter
• Length: 39 Centimeter
• Catheter Gauge: 24 French
• Lumen/Inner Diameter: 8 Millimeter
• Length: 39 Centimeter
• Catheter Gauge: 24 French
• Lumen/Inner Diameter: 8 Millimeter
• Length: 39 Centimeter
• Catheter Gauge: 24 French
• Lumen/Inner Diameter: 8 Millimeter
• Length: 39 Centimeter
• Catheter Gauge: 24 French
• Lumen/Inner Diameter: 8 Millimeter
• Length: 39 Centimeter
• Catheter Gauge: 24 French
• Lumen/Inner Diameter: 8 Millimeter
• Length: 39 Centimeter
• Catheter Gauge: 24 French
• Lumen/Inner Diameter: 8 Millimeter
• Length: 39 Centimeter
• Catheter Gauge: 24 French
• Lumen/Inner Diameter: 8 Millimeter
• Length: 39 Centimeter
• Catheter Gauge: 24 French
• Lumen/Inner Diameter: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132659036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160254

FDA Product Code

• DYB: Introducer, catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-10
• Device Publish Date: 2024-12-02

Devices Manufactured by W. L. Gore & Associates, Inc.

• 00733132658855 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath PI 33cmx10Fr
• 00733132658862 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath PI 45cmx10Fr
• 00733132658879 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath PI 65cmx10Fr
• 00733132658886 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath PI 33cmx11Fr
• 00733132658893 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath Ao 33cmx12Fr
• 00733132658909 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath Ao 45cmx12Fr
• 00733132658916 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath IC 65cmx12Fr
• 00733132658923 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath Ao 33cmx14Fr