Genesis MNS with Model-S 001-011000-3

GUDID M58800101100030

"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. "

STEREOTAXIS, INC.

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Primary Device IDM58800101100030
NIH Device Record Key888c8dad-7934-4641-810e-6a929b829ae8
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenesis MNS with Model-S
Version Model Number1.1 Model-S
Catalog Number001-011000-3
Company DUNS024942265
Company NameSTEREOTAXIS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM58800101100030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PJBCatheter Remote Control System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-28
Device Publish Date2020-08-20

Devices Manufactured by STEREOTAXIS, INC.

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M588001004115110 - Cardiodrive System2022-06-14 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
M588001004115120 - Cardiodrive System2022-06-14 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
M58800100111410 - Hemostasis Adapter2021-12-22 Hemostasis Adapter IV Spares, Box, Device Count(5)
M58800101100010 - Genesis (MNS) with Siemens2020-08-28 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-S2020-08-28"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-S2020-08-28 "Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left
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