| Primary Device ID | 08717648232725 |
| NIH Device Record Key | f3188a12-0ab8-49da-b8a5-aa7a34b5ab39 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NC TREK NEO™ |
| Version Model Number | 1400400-15 |
| Catalog Number | 1400400-15 |
| Company DUNS | 964569052 |
| Company Name | ABBOTT VASCULAR INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 15 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717648232725 [Primary] |
| LOX | Catheters, transluminal coronary angioplasty, percutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-23 |
| Device Publish Date | 2022-08-15 |
| 08717648232893 | NC TREK NEO™ Coronary Dilatation Catheter 6.00 mm X 20 mm / Rapid-Exchange |
| 08717648232886 | NC TREK NEO™ Coronary Dilatation Catheter 6.00 mm X 15 mm / Rapid-Exchange |
| 08717648232879 | NC TREK NEO™ Coronary Dilatation Catheter 6.00 mm X 12 mm / Rapid-Exchange |
| 08717648232855 | NC TREK NEO™ Coronary Dilatation Catheter 5.50 mm X 20 mm / Rapid-Exchange |
| 08717648232848 | NC TREK NEO™ Coronary Dilatation Catheter 5.50 mm X 15 mm / Rapid-Exchange |
| 08717648232831 | NC TREK NEO™ Coronary Dilatation Catheter 5.50 mm X 12 mm / Rapid-Exchange |
| 08717648232817 | NC TREK NEO™ Coronary Dilatation Catheter 5.00 mm X 20 mm / Rapid-Exchange |
| 08717648232800 | NC TREK NEO™ Coronary Dilatation Catheter 5.00 mm X 15 mm / Rapid-Exchange |
| 08717648232794 | NC TREK NEO™ Coronary Dilatation Catheter 5.00 mm X 12 mm / Rapid-Exchange |
| 08717648232787 | NC TREK NEO™ Coronary Dilatation Catheter 5.00 mm X 8 mm / Rapid-Exchange |
| 08717648232770 | NC TREK NEO™ Coronary Dilatation Catheter 4.50 mm X 20 mm / Rapid-Exchange |
| 08717648232763 | NC TREK NEO™ Coronary Dilatation Catheter 4.50 mm X 15 mm / Rapid-Exchange |
| 08717648232756 | NC TREK NEO™ Coronary Dilatation Catheter 4.50 mm X 12 mm / Rapid-Exchange |
| 08717648232749 | NC TREK NEO™ Coronary Dilatation Catheter 4.50 mm X 8 mm / Rapid-Exchange |
| 08717648232732 | NC TREK NEO™ Coronary Dilatation Catheter 4.00 mm X 20 mm / Rapid-Exchange |
| 08717648232725 | NC TREK NEO™ Coronary Dilatation Catheter 4.00 mm X 15 mm / Rapid-Exchange |
| 08717648232718 | NC TREK NEO™ Coronary Dilatation Catheter 4.00 mm X 12 mm / Rapid-Exchange |
| 08717648232701 | NC TREK NEO™ Coronary Dilatation Catheter 4.00 mm X 8 mm / Rapid-Exchange |
| 08717648232695 | NC TREK NEO™ Coronary Dilatation Catheter 3.75 mm X 20 mm / Rapid-Exchange |
| 08717648232688 | NC TREK NEO™ Coronary Dilatation Catheter 3.75 mm X 15 mm / Rapid-Exchange |
| 08717648232671 | NC TREK NEO™ Coronary Dilatation Catheter 3.75 mm X 12 mm / Rapid-Exchange |
| 08717648232664 | NC TREK NEO™ Coronary Dilatation Catheter 3.75 mm X 8 mm / Rapid-Exchange |
| 08717648232657 | NC TREK NEO™ Coronary Dilatation Catheter 3.50 mm x 25 mm / Rapid-Exchange |
| 08717648232640 | NC TREK NEO™ Coronary Dilatation Catheter 3.50 mm x 20 mm / Rapid-Exchange |
| 08717648232633 | NC TREK NEO™ Coronary Dilatation Catheter 3.50 mm x 15 mm / Rapid-Exchange |
| 08717648232626 | NC TREK NEO™ Coronary Dilatation Catheter 3.50 mm x 12 mm / Rapid-Exchange |
| 08717648232619 | NC TREK NEO™ Coronary Dilatation Catheter 3.50 mm x 8 mm / Rapid-Exchange |
| 08717648232602 | NC TREK NEO™ Coronary Dilatation Catheter 3.50 mm x 6 mm / Rapid-Exchange |
| 08717648232596 | NC TREK NEO™ Coronary Dilatation Catheter 3.25 mm x 20 mm / Rapid-Exchange |
| 08717648232589 | NC TREK NEO™ Coronary Dilatation Catheter 3.25 mm x 15 mm / Rapid-Exchange |
| 08717648232572 | NC TREK NEO™ Coronary Dilatation Catheter 3.25 mm x 12 mm / Rapid-Exchange |
| 08717648232565 | NC TREK NEO™ Coronary Dilatation Catheter 3.25 mm x 8 mm / Rapid-Exchange |
| 08717648232558 | NC TREK NEO™ Coronary Dilatation Catheter 3.25 mm x 6 mm / Rapid-Exchange |
| 08717648232541 | NC TREK NEO™ Coronary Dilatation Catheter 3.00 mm x 25 mm / Rapid-Exchange |
| 08717648232534 | NC TREK NEO™ Coronary Dilatation Catheter 3.00 mm x 20 mm / Rapid-Exchange |
| 08717648232527 | NC TREK NEO™ Coronary Dilatation Catheter 3.00 mm x 15 mm / Rapid-Exchange |
| 08717648232510 | NC TREK NEO™ Coronary Dilatation Catheter 3.00 mm x 12 mm / Rapid-Exchange |
| 08717648232503 | NC TREK NEO™ Coronary Dilatation Catheter 3.00 mm x 8 mm / Rapid-Exchange |
| 08717648232497 | NC TREK NEO™ Coronary Dilatation Catheter 3.00 mm x 6 mm / Rapid-Exchange |
| 08717648232480 | NC TREK NEO™ Coronary Dilatation Catheter 2.75 mm x 20 mm / Rapid-Exchange |
| 08717648232473 | NC TREK NEO™ Coronary Dilatation Catheter 2.75 mm x 15 mm / Rapid-Exchange |
| 08717648232466 | NC TREK NEO™ Coronary Dilatation Catheter 2.75 mm x 12 mm / Rapid-Exchange |
| 08717648232459 | NC TREK NEO™ Coronary Dilatation Catheter 2.75 mm x 8 mm / Rapid-Exchange |
| 08717648232442 | NC TREK NEO™ Coronary Dilatation Catheter 2.75 mm x 6 mm / Rapid-Exchange |
| 08717648232435 | NC TREK NEO™ Coronary Dilatation Catheter 2.50 X 25 mm / Rapid-Exchange |
| 08717648232428 | NC TREK NEO™ Coronary Dilatation Catheter 2.50 X 20 mm / Rapid-Exchange |
| 08717648232411 | NC TREK NEO™ Coronary Dilatation Catheter 2.50 X 15 mm / Rapid-Exchange |
| 08717648232404 | NC TREK NEO™ Coronary Dilatation Catheter 2.50 X 12 mm / Rapid-Exchange |
| 08717648232398 | NC TREK NEO™ Coronary Dilatation Catheter 2.50 X 8 mm / Rapid-Exchange |
| 08717648232381 | NC TREK NEO™ Coronary Dilatation Catheter 2.50 X 6 mm / Rapid-Exchange |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NC TREK NEO 90086663 not registered Live/Pending |
Abbott Cardiovascular Systems, Inc. 2020-07-31 |