Primary Device ID | M58800101100010 |
NIH Device Record Key | 23228347-d8a9-48e1-8068-97054b22abee |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Genesis (MNS) with Siemens |
Version Model Number | 1.1 Siemens |
Catalog Number | 001-011000-1 |
Company DUNS | 024942265 |
Company Name | STEREOTAXIS, 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 | 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 | true |
OTC Over-The-Counter | false |
M588020004500370 - Navigant | 2023-05-03 The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS). The MNS with NWS is intended t |
M588001004115110 - Cardiodrive System | 2022-06-14 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E |
M588001004115120 - Cardiodrive System | 2022-06-14 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E |
M58800100111410 - Hemostasis Adapter | 2021-12-22 Hemostasis Adapter IV Spares, Box, Device Count(5) |
M58800101100010 - Genesis (MNS) with Siemens | 2020-08-28Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and
left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired
direction. |
M58800101100010 - Genesis (MNS) with Siemens | 2020-08-28 Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and
left |
M58800101100030 - Genesis MNS with Model-S | 2020-08-28 "Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and
left |