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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® HEARTMATE®, SYSTEM MONITOR - 00813024010852

SYSTEM MONITOR
Thoratec Corporation
1286A-US
In Commercial Distribution

  • 00813024010852 ()
1286A-US

  • Image display unit, colour

THORATEC® HEARTMATE II®, SEALED OUTFLOW SHORT BEND RELIEF, 7.6CM (3 IN) - 00813024010814

No Description
Thoratec Corporation
104692
In Commercial Distribution

  • 00813024010814 ()
104692

  • Implantable ventricular circulatory assist system outflow cannula, animal-derived

THORATEC® HEARTMATE®, BATTERY HOLSTER, EP - 00813024010760

No Description
Thoratec Corporation
103479
In Commercial Distribution

  • 00813024010760 ()
  • 00813024012436 ()
103479

  • Personal device holder, reusable

THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP - 00813024010630

No Description
Thoratec Corporation
103696
In Commercial Distribution

  • 00813024010630 ()
103696

  • Implantable ventricular circulatory assist system control unit

THORATEC® HEARTMATE II®, LVAS IMPLANT KIT, US, EP - 00813024010616

No Description
Thoratec Corporation
103695
In Commercial Distribution

  • 00813024010616 ()
103695

  • Implantable ventricular circulatory assist system

THORATEC® HEARTMATE®, TRAVEL BAG - 00813024010555

No Description
Thoratec Corporation
1260
In Commercial Distribution

  • 00813024010555 ()
1260

  • Personal device holder, reusable

THORATEC® HEARTMATE® GOGEAR®, CONSOLIDATED BAG, BEIGE - 00813024010524

No Description
Thoratec Corporation
104223
In Commercial Distribution

  • 00813024010524 ()
104223

  • Medical bag

THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG - 00813024010456

No Description
Thoratec Corporation
104216
In Commercial Distribution

  • 00813024010456 ()
  • 00813024012443 ()
104216

  • Personal device holder, reusable

THORATEC® HEARTMATE® XVE AND HEARTMATE II®, EMERGENCY POWER PACK CABLE - 00813024010425

No Description
Thoratec Corporation
1226
In Commercial Distribution

  • 00813024010425 ()
1226

  • Electrical-only medical device connection cable, reusable

EXPLANT RETURN KIT - 00813024010241

No Description
Thoratec Corporation
28717
In Commercial Distribution

  • 00813024010241 ()
28717

  • Contaminated waste container
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