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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® XVE AND HEARTMATE II®, APICAL CORING KNIFE - 00813024010227

No Description
Thoratec Corporation
1050
In Commercial Distribution

  • 00813024010227 ()
1050

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

THORATEC® HEARTMATE II®, SURGICAL SIZER - 00813024010203

No Description
Thoratec Corporation
102772
In Commercial Distribution

  • 00813024010203 ()
102772

  • Surgical implant template, reusable

THORATEC® HEARTMATE II®, TUNNELER - 00813024010197

No Description
Thoratec Corporation
102137
In Commercial Distribution

  • 00813024010197 ()
102137

  • Vascular graft tunneller

THORATEC® HEARTMATE II®, OUTFLOW CANNULA BEND RELIEF, 7.6 CM (3 IN) - 00813024010180

No Description
Thoratec Corporation
102781
In Commercial Distribution

  • 00813024010180 ()
102781

  • Implantable ventricular circulatory assist system outflow cannula, synthetic polymer

THORATEC® HEARTMATE II®, INFLOW CONDUIT - 00813024010166

No Description
Thoratec Corporation
102564
In Commercial Distribution

  • 00813024010166 ()
102564

  • Implantable ventricular circulatory assist system inflow cannula, synthetic polymer

THORATEC® HEARTMATE® XVE AND HEARTMATE II®, DISPLAY MODULE - 00813024010135

No Description
Thoratec Corporation
1280N
In Commercial Distribution

  • 00813024010135 ()
1280N

  • Image display unit, colour

THORATEC® HEARTMATE® XVE AND HEARTMATE II®, BATTERY MODULE - 00813024010128

No Description
Thoratec Corporation
1264
In Commercial Distribution

  • 00813024010128 ()
1264

  • Primary battery

THORATEC® HEARTMATE® XVE, BATTERY CLIP SET - 00813024010074

No Description
Thoratec Corporation
1237
In Commercial Distribution

  • 00813024010074 ()
  • 00813024012399 ()
1237

  • Secondary battery

THORATEC® HEARTMATE® XVE AND HEARTMATE II®, RECHARGEABLE BATTERY SET - 00813024010067

No Description
Thoratec Corporation
2025
In Commercial Distribution

  • 00813024010067 ()
  • 00813024012429 ()
2025

  • Secondary battery

UVAR XTS - 20705030200027

UVAR XTS Procedural Kit (125 ml)
THERAKOS, INC.
XT125
Not in Commercial Distribution

  • 20705030200027 ()
  • 10705030200020 ()
XT125

  • Photopheresis system blood set
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