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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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THORATEC® PVAD™, VENTRICULAR ASSIST DEVICE - BLOOD PUMP - 00813024012009

VAD, STERILE, CLINICAL
Thoratec Corporation
14086-2550-000
In Commercial Distribution

  • 00813024012009 ()
14086-2550-000

  • External ventricular circulatory assist system

Neuro PR app 2400.U - 04035479188733

No Description
BIOTRONIK SE & Co. KG
493241
In Commercial Distribution

  • 04035479188733 ()
493241

  • Implantable electrical stimulation device management software

Neuro CP app 2300.U - 04035479185817

No Description
BIOTRONIK SE & Co. KG
487878
In Commercial Distribution

  • 04035479185817 ()
487878

  • Implantable electrical stimulation device management software

BIOTRONIK - 04035479177416

No Description
BIOTRONIK SE & Co. KG
MyHomeStream 2100.U
In Commercial Distribution

  • 04035479177416 ()
469255

  • Implantable electrical stimulation device management software

BIOTRONIK - 04035479177409

No Description
BIOTRONIK SE & Co. KG
HomeStreamCP 2100.U
In Commercial Distribution

  • 04035479177409 ()
469254

  • Implantable electrical stimulation device management software

Bionic Navigator™ 3D - 08714729995203

4.0 Installer
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-7101-400
In Commercial Distribution

  • 08714729995203 ()


  • Implantable electrical stimulation device management software

Bionic Navigator™ - 08714729991380

1.2 Installer
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-7101-102-W10
In Commercial Distribution

  • 08714729991380 ()


  • Implantable electrical stimulation device management software

Bionic Navigator™ 3D - 08714729991373

2.10 Installer
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-7101-210-W10
In Commercial Distribution

  • 08714729991373 ()


  • Implantable electrical stimulation device management software

Bionic Navigator™ 3D - 08714729991366

2.20 Installer
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-7101-220-W10
In Commercial Distribution

  • 08714729991366 ()


  • Implantable electrical stimulation device management software

Axonics - 10810005340035

Clinician Programmer
AXONICS MODULATION TECHNOLOGIES, INC.
2501
In Commercial Distribution

  • 10810005340035 ()
2501

  • Implantable incontinence-control electrical stimulation system programmer, line-powered
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