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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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emPOWER - B155EM40

Wireless Tuning Device
BIONX MEDICAL TECHNOLOGIES, INC.
em4
In Commercial Distribution

  • B155EM40 ()


  • Portable computer

BiOM T2 - B15520012190

BiOM T2 Wireless Tuning Device
BIONX MEDICAL TECHNOLOGIES, INC.
2001219
In Commercial Distribution

  • B15520012190 ()


  • Portable computer

ViraChip Scanner - EVIRUVCSCA1

ViraChip Scanner
Viramed Biotech AG
V-UVCSCA
In Commercial Distribution

  • EVIRUVCSCA1 ()
V-UVCSCA

  • Microplate digital imaging scanner IVD

ViraChip Reader - EVIRUVCCAM1

ViraChip Reader
Viramed Biotech AG
V-UVCCAM
In Commercial Distribution

  • EVIRUVCCAM1 ()
V-UVCCAM

  • Microplate digital imaging scanner IVD

Cinema MAS & MMS - M58802000780030

The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
Stereotaxis, Inc.
DMS-100
In Commercial Distribution

  • M58802000780030 ()
020-007800-3

  • Cardiac mapping system workstation

Navigant - 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.
5.0.7
In Commercial Distribution

  • M588020004500360 ()
020-004500-36

  • Cardiac mapping system workstation

Vdrive Drape - M58800101005611

"The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during the performance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance of electrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when used in conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic Navigation System (MNS). "
Stereotaxis, Inc.
1
Not in Commercial Distribution

  • M58800101005611 ()
  • M58800101005610 ()
001-010056-1

  • Cardiac mapping system workstation

Odyssey - M58800100790010

The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
Stereotaxis, Inc.
Link
In Commercial Distribution

  • M58800100790010 ()
001-007900-1

  • Cardiac mapping system workstation

Odyssey Cinema - M58800100784010

The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
Stereotaxis, Inc.
Studio
In Commercial Distribution

  • M58800100784010 ()
001-007840-1

  • Cardiac mapping system workstation

Odyssey Enterprise Interface - M58800100781010

The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
Stereotaxis, Inc.
EIF
In Commercial Distribution

  • M58800100781010 ()
001-007810-1

  • Cardiac mapping system workstation
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