| Primary Device ID | H373GEFA01530039 |
| NIH Device Record Key | 7b6b4180-ab31-4ece-ad77-28ee4c6709c7 |
| Commercial Distribution Discontinuation | 2019-12-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | GORE Embolic Filter |
| Version Model Number | GEFA015300 |
| Catalog Number | GEFA015300 |
| 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 | true |
| 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 |
| Phone | +1(800)528-8763 |
| mpdcustomercare@wlgore.com | |
| Phone | +1(800)528-8763 |
| mpdcustomercare@wlgore.com |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00733132618262 [Primary] |
| HIBCC | H373GEFA01530039 [Secondary] |
| NTE | Temporary Carotid Catheter for Embolic Capture |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-12-12 |
| Device Publish Date | 2017-02-13 |
| 00733132618286 | 7MM FILTER ON 300CM GUIDEWIRE |
| 00733132618279 | 5MM FILTER ON 185CM GUIDEWIRE |
| H373GEFA01530039 | 5MM FILTER ON 300CM GUIDEWIRE |
| 00733132618255 | 7MM FILTER ON 185CM GUIDEWIRE |