Primary Device ID | M58800101100030 |
NIH Device Record Key | 888c8dad-7934-4641-810e-6a929b829ae8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Genesis MNS with Model-S |
Version Model Number | 1.1 Model-S |
Catalog Number | 001-011000-3 |
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 |
Phone | 13146786100 |
info@stereotaxis.com | |
Phone | 13146786100 |
info@stereotaxis.com | |
Phone | 13146786100 |
info@stereotaxis.com | |
Phone | 13146786100 |
info@stereotaxis.com | |
Phone | 13146786100 |
info@stereotaxis.com | |
Phone | 13146786100 |
info@stereotaxis.com | |
Phone | 13146786100 |
info@stereotaxis.com | |
Phone | 13146786100 |
info@stereotaxis.com | |
Phone | 13146786100 |
info@stereotaxis.com | |
Phone | 13146786100 |
info@stereotaxis.com | |
Phone | 13146786100 |
info@stereotaxis.com | |
Phone | 13146786100 |
info@stereotaxis.com | |
Phone | 13146786100 |
info@stereotaxis.com | |
Phone | 13146786100 |
info@stereotaxis.com | |
Phone | 13146786100 |
info@stereotaxis.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M58800101100030 [Primary] |
PJB | Catheter Remote Control System |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-08-28 |
Device Publish Date | 2020-08-20 |
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 | 2020-08-28 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 heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction. " |
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 |