GORE® DrySeal Flex Introducer Sheath GDSF1033
GUDID 00733132658855
DrySeal Hydro Flex Sheath PI 33cmx10Fr
W. L. Gore & Associates, Inc.
Vascular catheter introduction set, nonimplantable| Primary Device ID | 00733132658855 |
| NIH Device Record Key | 09019eac-79a6-473c-917a-bbe1f9d07a50 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GORE® DrySeal Flex Introducer Sheath |
| Version Model Number | GDSF1033 |
| Catalog Number | GDSF1033 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00733132658855 [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 |
Trademark Results [GORE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GORE 98828019 not registered Live/Pending |
W. L. Gore & Associates, Inc. 2024-10-30 |
 GORE 87781450 not registered Live/Pending |
W. L. Gore & Associates, Inc. 2018-02-02 |
 GORE 87467566 not registered Live/Pending |
W. L. Gore & Associates, Inc. 2017-05-30 |
 GORE 87274539 5470584 Live/Registered |
W. L. Gore & Associates, Inc. 2016-12-20 |
 GORE 86558569 not registered Dead/Abandoned |
W. L. Gore & Associates, Inc. 2015-03-10 |
 GORE 86460965 4772936 Live/Registered |
W. L. Gore & Associates, Inc. 2014-11-21 |
 GORE 85919161 not registered Dead/Abandoned |
W. L. Gore & Associates, Inc. 2013-04-30 |
 GORE 85919122 5151413 Live/Registered |
W. L. Gore & Associates, Inc. 2013-04-30 |
 GORE 85825447 not registered Dead/Abandoned |
W. L. Gore & Associates, Inc. 2013-01-17 |
 GORE 85705135 4822432 Live/Registered |
W. L. Gore & Associates, Inc. 2012-08-16 |
 GORE 85337378 4120927 Live/Registered |
W. L. Gore & Associates, Inc. 2011-06-03 |
 GORE 78496951 not registered Dead/Abandoned |
W. L. Gore & Associates, Inc. 2004-10-08 |
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