GORE® DrySeal Flex Introducer Sheath GDSF1245

GUDID 00733132658909

DrySeal Hydro Flex Sheath Ao 45cmx12Fr

W. L. Gore & Associates, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00733132658909
• NIH Device Record Key: a5162e28-643c-4eac-ba50-17925593a072
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE® DrySeal Flex Introducer Sheath
• Version Model Number: GDSF1245
• Catalog Number: GDSF1245
• 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: true
• 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: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132658909 [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: true

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

On-Brand Devices [GORE® DrySeal Flex Introducer Sheath]

• 00733132659067: DrySeal Hydro Flex Sheath Ao 65cmx26Fr
• 00733132659050: DrySeal Hydro Flex Sheath Ao 33cmx26Fr
• 00733132659043: DrySeal Hydro Flex Sheath Ao 65cmx22Fr
• 00733132659029: DrySeal Hydro Flex Sheath Ao 65cmx22Fr
• 00733132659012: DrySeal Hydro Flex Sheath Ao 33cmx22Fr
• 00733132659005: DrySeal Hydro Flex Sheath Ao 65cmx20Fr
• 00733132658992: DrySeal Hydro Flex Sheath Ao 33cmx20Fr
• 00733132658985: DrySeal Hydro Flex Sheath IC 65cmx18Fr
• 00733132658978: DrySeal Hydro Flex Sheath Ao 33cmx18Fr
• 00733132658961: DrySeal Hydro Flex Sheath IC 65cmx16Fr
• 00733132658954: DrySeal Hydro Flex Sheath Ao 33cmx16Fr
• 00733132658947: DrySeal Hydro Flex Sheath Ao 33cmx15Fr
• 00733132658930: DrySeal Hydro Flex Sheath IC 65cmx14Fr
• 00733132658923: DrySeal Hydro Flex Sheath Ao 33cmx14Fr
• 00733132658916: DrySeal Hydro Flex Sheath IC 65cmx12Fr
• 00733132658909: DrySeal Hydro Flex Sheath Ao 45cmx12Fr
• 00733132658893: DrySeal Hydro Flex Sheath Ao 33cmx12Fr
• 00733132658886: DrySeal Hydro Flex Sheath PI 33cmx11Fr
• 00733132658879: DrySeal Hydro Flex Sheath PI 65cmx10Fr
• 00733132658862: DrySeal Hydro Flex Sheath PI 45cmx10Fr
• 00733132658855: DrySeal Hydro Flex Sheath PI 33cmx10Fr