| Primary Device ID | 00733132601936 |
| NIH Device Record Key | 9a6d90f2-4668-4743-9288-437159858660 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GORE PRECLUDE Dura Substitute |
| Version Model Number | 1PDS152 |
| Catalog Number | 1PDS152 |
| 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 |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00733132601936 [Primary] |
| GXQ | Dura Substitute |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-03-07 |
| 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 |