GORE DRYSEAL FLEX Introducer Sheath DSF1833

GUDID 00733132630042

W. L. Gore & Associates, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00733132630042
• NIH Device Record Key: 2675d248-40c1-416f-9c01-064c8cf50e34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE DRYSEAL FLEX Introducer Sheath
• Version Model Number: DSF1833
• Catalog Number: DSF1833
• 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: +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
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French
• Length: 33 Centimeter
• Catheter Gauge: 18 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132630042 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-28
• Device Publish Date: 2016-07-22

On-Brand Devices [GORE DRYSEAL FLEX Introducer Sheath]

• 00733132630950: DSF2433
• 00733132630103: DSF2633
• 00733132630073: DSF2233
• 00733132630066: DSF2033
• 00733132630042: DSF1833
• 00733132630028: DSF1633
• 00733132630011: DSF1533
• 00733132630004: DSF1433
• 00733132629961: DSF1233
• 00733132628421: DSF2665
• 00733132628407: DSF2465
• 00733132628384: DSF2265
• 00733132628360: DSF2065
• 00733132628117: DSF1245
• 00733132629978: DSF1033
• 00733132628261: DSF1065
• 00733132628094: DSF1045
• 00733132628346: DSF1865
• 00733132628322: DSF1665
• 00733132628308: DSF1465
• 00733132628285: DSF1265
• 00733132629985: GORE DRYSEAL FLEX Introducer Sheath 33cm 11Fr Hydrophilic Coating