| Primary Device ID | H373HX202534 |
| NIH Device Record Key | 300610eb-fa72-4fde-9422-2e40280dfe84 |
| Commercial Distribution Discontinuation | 2016-03-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | GORE HELEX Septal Occluder |
| Version Model Number | HX2025 |
| Company DUNS | 967358115 |
| Company Name | W. L. Gore & Associates, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
| Outer Diameter | 25 Millimeter |
| Outer Diameter | 25 Millimeter |
| Outer Diameter | 25 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 25 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00733132606993 [Primary] |
| HIBCC | H373HX202534 [Secondary] |
| MLV | Transcatheter Septal Occluder |
| 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 | 2017-02-13 |
| H373HX203535 | HX2035 |
| H373HX203030 | HX2030 |
| H373HX202534 | HX2025 |
| H373HX20203 | HX2020 |
| H373HX201533 | HX2015 |