| Primary Device ID | 06952450948095 |
| NIH Device Record Key | 8372a84b-cd9a-4e0a-8543-97ecd509e75c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PathBuilder Transseptal Guiding Introducer |
| Version Model Number | TSL0638 |
| Company DUNS | 542965535 |
| Company Name | Shanghai Microport Ep Medtech Co., Ltd. |
| 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 | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |