| Primary Device ID | H373BCL264536 |
| NIH Device Record Key | 73adb5b2-3b2c-49ba-9053-635bb908f175 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GORE Tri-Lobe Balloon Catheter |
| Version Model Number | BCL2645 |
| Catalog Number | BCL2645 |
| 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 |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Length | 108 Centimeter |
| Length | 104 Centimeter |
| Catheter Gauge | 18 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00733132605224 [Primary] |
| HIBCC | H373BCL264536 [Secondary] |
| DQY | CATHETER, PERCUTANEOUS |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2017-02-13 |
| H373BCM163434 | TRI-LOBE BALLOON MEDIUM CATH |
| H373BCL264536 | TRI-LOBE BALLOON LARGE CATH |