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 |
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 | 2021-12-22Hemostasis Adapter IV Spares, Box, Device Count(5) |
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 |