Navigant 020-004500-36
GUDID M588020004500360
The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS). The MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS.
Stereotaxis, Inc.
Cardiac mapping system workstation| Primary Device ID | M588020004500360 |
| NIH Device Record Key | 929dc7dc-aea9-4733-a977-5daa9d1b59b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Navigant |
| Version Model Number | 5.0.7 |
| Catalog Number | 020-004500-36 |
| 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 | false |
| 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 |
Customer Support Contacts
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M588020004500360 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193147
FDA Product Code
| NDQ | System, Catheter Or Guidewire, Steerable (Magnetic) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-07-17 |
| Device Publish Date | 2022-06-06 |
On-Brand Devices [Navigant]
| M588020004500370 | The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS) |
| M588020004500360 | The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS) |
| M588020004500260 | The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe MNS with NWS is i |
| M588020004500220 | The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe MNS with NWS is i |
| M588020004500210 | The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe MNS with NWS is i |
Trademark Results [Navigant]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NAVIGANT 87543528 5401542 Live/Registered |
Navigant Consulting, Inc. 2017-07-26 |
 NAVIGANT 78966215 not registered Dead/Abandoned |
Credit Union Central Falls 2006-09-01 |
 NAVIGANT 78370676 4626614 Live/Registered |
Stereotaxis, Inc. 2004-02-19 |
 NAVIGANT 78177090 not registered Dead/Abandoned |
Gambro Pathogen Reduction Technologies,Inc. 2002-10-22 |
 NAVIGANT 78177084 not registered Dead/Abandoned |
Gambro Pathogen Reduction Technologies,Inc. 2002-10-22 |
 NAVIGANT 78105620 not registered Dead/Abandoned |
Stereotaxis, Inc. 2002-01-30 |
 NAVIGANT 77207039 3452419 Live/Registered |
NAVIGANT CONSULTING, INC. 2007-06-15 |
 NAVIGANT 75673493 not registered Dead/Abandoned |
Metzler Group, Inc., The 1999-04-01 |
 NAVIGANT 75596878 2714796 Live/Registered |
NAVIGANT CONSULTING, INC. 1998-11-30 |
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