| Primary Device ID | 00815671020260 |
| NIH Device Record Key | e1620338-2f2f-4fc0-9e8d-1f19fc62237b |
| Commercial Distribution Discontinuation | 2016-09-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Sensei® |
| Version Model Number | SRS200 |
| Catalog Number | SRS200 |
| Company DUNS | 128941304 |
| Company Name | HANSEN MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 1-650-404-5844 |
| xx@xx.xx | |
| Phone | 1-650-404-5844 |
| xx@xx.xx | |
| Phone | 1-650-404-5844 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815671020260 [Primary] |
| DXX | System, Catheter Control, Steerable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-30 |
| 00815671020260 | Sensei X2 Robotic System 120V |
| 00815671020246 | Sensei X Robotic System Reconditioned 120V |