| Primary Device ID | 00733132657902 |
| NIH Device Record Key | 5a74949e-5e13-466e-b641-2a7f221d297a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GORE TIPS Set |
| Version Model Number | TSET1016 |
| Catalog Number | TSET1016 |
| 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 | true |
| Serial Number | false |
| 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 |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | 800-528-8763 |
| mpdcustomercare@wlgore.com |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00733132657902 [Primary] |
| DYB | Introducer, Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-23 |
| Device Publish Date | 2024-07-15 |
| 00733132619832 - GORE® Tri-Lobe Balloon Catheter | 2025-06-19 TRI-LOBE BALLOON CATHETER 18Fr |
| 00733132619849 - GORE® Tri-Lobe Balloon Catheter | 2025-06-19 TRI-LOBE BALLOON CATHETER 18Fr |
| 00733132661664 - GORE TAG Conformable Thoracic Stent Graft | 2025-03-26 CTAG CMDS 34MMX28MMX15CM 22Fr |
| 00733132661671 - GORE TAG Conformable Thoracic Stent Graft | 2025-03-26 CTAG CMDS 45MMX37MMX15CM 24Fr |
| 00733132661688 - GORE TAG Conformable Thoracic Stent Graft | 2025-03-26 CTAG CMDS 37MMX31MMX15CM 22Fr |
| 00733132661695 - GORE TAG Conformable Thoracic Stent Graft | 2025-03-26 CTAG CMDS 40MMX34MMX15CM 22Fr |
| 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 |