| Primary Device ID | H373IRST08080080L36 |
| NIH Device Record Key | a252b0b2-f55c-4acf-be79-62ba02cf2496 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GORE INTERING Vascular Graft |
| Version Model Number | IRST08080080L |
| Catalog Number | IRST08080080L |
| 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 |
| Length | 80 Centimeter |
| Length | 80 Centimeter |
| Length | 80 Centimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 80 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00733132607303 [Primary] |
| HIBCC | H373IRST08080080L36 [Secondary] |
| DSY | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-01-28 |
| Device Publish Date | 2017-02-13 |
| H373IRST08080080L36 | INTERING STR T8MM 80CM RS X 80 |
| H373IRST08060060L32 | INTERING STR T8MM 60CM RS X 60 |
| H373IRST08040040L3 | INTERING STR T8MM 40CM RS X 40 |
| H373IRST07080080L35 | INTERING STR T7MM 80CM RS X 80 |
| H373IRST07060060L31 | INTERING STR T7MM 60CM RS X 60 |
| H373IRST07040040L3 | INTERING STR T7MM 40CM RS X 40 |
| H373IRST06080080L34 | INTERING STR T6MM 80CM RS X 80 |
| H373IRST06060060L30 | INTERING STR T6MM 60CM RS X 60 |
| H373IRST06040040L3 | INTERING STR T6MM 40CM RS X 40 |
| H373IRST06005005L3 | INTERING STR T6MM 5CM RS X 5 |
| 00733132607204 | INTERING STR 4-7MM 38CM RSX 45 |
| 00733132607198 | INTERING STR 4-6MM 38CM RSX 45 |
| H373IRS06040L36 | INTERING STR 6MM 40CM RS X 40 |
| H373IRS06010020L35 | INTERING STRETCH 6MM 10CMX20CM |
| 00733132607167 | INTERING STRETCH 6MM 5CM X45CM |
| H373IRS06005020L39 | INTERING STRETCH 6MM 5CM X20CM |
| 00733132607020 | INTERING 6MM 5CM X 45CM |