| Primary Device ID | 00853799007299 |
| NIH Device Record Key | 2e2fa2b6-85a9-4743-9e6c-da67d56c357e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tenzing 8 Delivery Catheter |
| Version Model Number | SA 0342 |
| Company DUNS | 067429673 |
| Company Name | ROUTE 92 MEDICAL |
| 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 | 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 |
| 00853799007701 - 8F Base Camp system 2.0 80cm | 2024-10-22 8F Base Camp system 2.0 80cm |
| 00853799007718 - 8F Base Camp system 2.0 80cm | 2024-10-22 8F Base Camp system 2.0 80cm; Contains 8F Base Camp system 2.0 80cm (00853799007701) |
| 00853799007725 - 8F Base Camp system 2.0 90cm | 2024-10-22 8F Base Camp system 2.0 90cm |
| 00853799007732 - 8F Base Camp system 2.0 90cm | 2024-10-22 8F Base Camp system 2.0 90cm; 8F Base Camp system 2.0 90cm (00853799007725) |
| 00853799007749 - FreeClimb 88 catheter, 125cm | 2024-07-09 FreeClimb 88 catheter, 125cm |
| 00853799007756 - FreeClimb 88 catheter, 132cm | 2024-07-09 FreeClimb 88 catheter, 132cm |
| 00853799007763 - FreeClimb 88 catheter, 125cm with Tenzing 8 | 2024-07-09 FreeClimb 88 catheter, 125cm with Tenzing 8; Contains Tenzing 8 Delivery Catheter (00853799007299) and FreeClimb 88 catheter, 12 |
| 00853799007770 - FreeClimb 88 catheter, 132cm with Tenzing 8 | 2024-07-09 FreeClimb 88 catheter, 132cm with Tenzing 8; Contains Tenzing 8 Delivery Catheter (00853799007299) and FreeClimb 88 catheter, 13 |