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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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CEMENTSYS KPT1002-CDS OIS XPDR 10/3
MEDTRONIC SOFAMOR DANEK, INC.
KPT1002-CDS
Not in Commercial Distribution

  • 00643169100657 ()


  • Balloon kyphoplasty kit
CEMENTSYS KPT1003-CDS AOIS XPDR 10/3
MEDTRONIC SOFAMOR DANEK, INC.
KPT1003-CDS
Not in Commercial Distribution

  • 00643169100640 ()


  • Balloon kyphoplasty kit
KIT KPT1005 KYPAK TRY 10/3 FF W/ONESTEP
MEDTRONIC SOFAMOR DANEK, INC.
KPT1005
Not in Commercial Distribution

  • 00643169100633 ()


  • Balloon kyphoplasty kit
CEMENTSYS KPT1005-CDS FF XPDR 10/3 1 STP
MEDTRONIC SOFAMOR DANEK, INC.
KPT1005-CDS
In Commercial Distribution

  • 00643169100626 ()


  • Balloon kyphoplasty kit
KIT KPT1501 KYPHOPAK TRAY 15/3 FF W/ITK
MEDTRONIC SOFAMOR DANEK, INC.
KPT1501
In Commercial Distribution

  • 00643169100619 ()


  • Instrument tray, reusable
CEMENTSYS KPT1502-CDS OIS XPDR 15/3
MEDTRONIC SOFAMOR DANEK, INC.
KPT1502-CDS
In Commercial Distribution

  • 00643169100602 ()


  • Balloon kyphoplasty kit
CEMENTSYS KPT1503-CDS AOIS XPDR 15/3
MEDTRONIC SOFAMOR DANEK, INC.
KPT1503-CDS
Not in Commercial Distribution

  • 00643169100596 ()


  • Balloon kyphoplasty kit
CEMENTSYS KPT1505-CDS FF XPDR 15/3 1 STP
MEDTRONIC SOFAMOR DANEK, INC.
KPT1505-CDS
In Commercial Distribution

  • 00643169100589 ()


  • Balloon kyphoplasty kit
KIT KPT2001 KYPHOPAK TRAY 20/3 FF W/ITK
MEDTRONIC SOFAMOR DANEK, INC.
KPT2001
In Commercial Distribution

  • 00643169100572 ()


  • Instrument tray, reusable
CEMENTSYS KPT2002-CDS OIS XPDR 20/3
MEDTRONIC SOFAMOR DANEK, INC.
KPT2002-CDS
In Commercial Distribution

  • 00643169100565 ()


  • Balloon kyphoplasty kit
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