| Primary Device ID | M58800100111410 |
| NIH Device Record Key | 3d740963-7fcc-45b4-ab4b-9388c355907d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hemostasis Adapter |
| Version Model Number | IV-1 |
| Catalog Number | 0010011141 |
| Company DUNS | 024942265 |
| Company Name | STEREOTAXIS, INC. |
| Device Count | 5 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M58800100111410 [Unit of Use] |
| HIBCC | M58800100111411 [Primary] |
| DQX | Wire, Guide, Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-22 |
| Device Publish Date | 2021-12-14 |
| M58800100175110 - QuikCAS Cardiodrive Sterile Components | 2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E |
| M5880010017711 - QuikCAS Hemostasis Adapter | 2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E |
| M5880010017712 - Cardiodrive Hemostasis Adapter - SJ | 2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E |
| M58800100230710 - Vdrive System | 2024-07-17 "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE |
| M58800100230720 - Vdrive System | 2024-07-17 "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE |
| M58800100242210 - V-CAS Catheter Advancement System | 2024-07-17 The Vdrive with V-CAS Disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible m |
| M58800100245210 - V-Loop Variable Loop Catheter Manipulator | 2024-07-17 The Vdrive with V-Loop disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loo |
| M58800100246910 - V-Sono Intracardiac Echo Manipulator | 2024-07-17 Vdrive with V-Sono is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection |