GORE DrySeal Sheath SDV1828

GUDID H373SDV18283

SDV INTRODUCER SHEATH 18F

W. L. Gore & Associates, Inc.

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• Primary Device ID: H373SDV18283
• NIH Device Record Key: 70c60838-2760-44a5-9502-95e41f9d6b19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE DrySeal Sheath
• Version Model Number: SDV1828
• Catalog Number: SDV1828
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter
• Outer Diameter: 7 Millimeter
• Length: 28 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132612147 [Primary]
HIBCC	H373SDV18283 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120428

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: 4
• Public Version Date: 2020-02-28
• Device Publish Date: 2017-02-13

On-Brand Devices [GORE DrySeal Sheath]

• 00733132620005: DRYSEAL LUBRICIOUS 26F Hydrophilic Coating
• 00733132619993: DRYSEAL LUBRICIOUS 24F Hydrophilic Coating
• 00733132619986: DRYSEAL LUBRICIOUS 22F Hydrophilic Coating
• 00733132619979: DRYSEAL LUBRICIOUS 20F Hydrophilic Coating
• 00733132619962: DRYSEAL LUBRICIOUS 18F Hydrophilic Coating
• 00733132619955: DRYSEAL LUBRICIOUS 16F Hydrophilic Coating
• 00733132619948: DRYSEAL LUBRICIOUS 14F Hydrophilic Coating
• 00733132619931: DRYSEAL LUBRICIOUS 12F
• 00733132612185: SDV INTRODUCER SHEATH 26F
• 00733132612178: SDV INTRODUCER SHEATH 24F
• 00733132612161: SDV INTRODUCER SHEATH 22F
• 00733132612154: SDV INTRODUCER SHEATH 20F
• H373SDV18283: SDV INTRODUCER SHEATH 18F
• 00733132612123: SDV INTRODUCER SHEATH 14F
• 00733132612116: SDV INTRODUCER SHEATH 12F