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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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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

Niobe Cover Drape - M58800100591011

Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction
Stereotaxis, Inc.
1
Not in Commercial Distribution

  • M58800100591011 ()
  • M58800100591010 ()
001-005910-1

  • Cardiac mapping system workstation

ON-Q* Pain Relief System with SOAKER* Catheter - 00193494000134

No Description
Avanos Medical, Inc.
PS6506-N
In Commercial Distribution

  • 10193494000131 ()
  • 00193494000134 ()
PS6506-N

  • Cardiac pulse generator programmer

CorPath GRX Cassette Duo - 00816280023192

No Description
Corindus, Inc.
319
In Commercial Distribution

  • 00816280023185 ()
  • 00816280023192 ()
319

  • Cardiac mapping system workstation

CorPath GRX Drape, Control Console - 00816280023116

No Description
Corindus, Inc.
311
In Commercial Distribution

  • 00816280023116 ()
  • 00816280023109 ()
311

  • Cardiac mapping system workstation

CorPath GRX Drape, Robotic Drive and Arm - 00816280023093

No Description
Corindus, Inc.
309
In Commercial Distribution

  • 00816280023093 ()
  • 00816280023086 ()
309

  • Cardiac mapping system workstation

CorPath GRX Drive Gear - 00816280023079

No Description
Corindus, Inc.
307
In Commercial Distribution

  • 00816280023079 ()
  • 00816280023062 ()
307

  • Cardiac mapping system workstation

CorPath GRX Cassette - 00816280023055

No Description
Corindus, Inc.
305
In Commercial Distribution

  • 00816280023055 ()
  • 00816280023048 ()
305

  • Cardiac mapping system workstation

CorPath 200 Robotic Drive Drape - 00816280022133

No Description
Corindus, Inc.
160-00828
Not in Commercial Distribution

  • 00816280022133 ()
  • 00816280022126 ()
160-00828

  • Cardiac mapping system workstation

CorPath 200 Joystick Covers - 00816280022119

No Description
Corindus, Inc.
160-00692
Not in Commercial Distribution

  • 00816280022119 ()
  • 00816280022102 ()
160-00692

  • Cardiac mapping system workstation
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