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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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Percepta™ Quad CRT-P MRI SureScan™ - 00643169891418

CRTP W4TR01 PERCEPTA QUAD CRTP MRI US
MEDTRONIC, INC.
W4TR01
In Commercial Distribution

  • 00643169891418 ()


  • Cardiac resynchronization therapy implantable pacemaker

Percepta™ CRT-P MRI SureScan™ - 00643169891401

CRTP W1TR01 PERCEPTA CRTP MRI US
MEDTRONIC, INC.
W1TR01
In Commercial Distribution

  • 00643169891401 ()


  • Cardiac resynchronization therapy implantable pacemaker

Advisa™ DR - 00643169050730

IPG A4DR01 ADVISA DR US MKT NON MRI
MEDTRONIC, INC.
A4DR01
Not in Commercial Distribution

  • 00643169050730 ()


  • Dual-chamber implantable pacemaker, rate-responsive

Viva™ XT CRT-D - 00643169007246

CRT-D DTBA1D1 VIVA XT US IS1/DF1
MEDTRONIC, INC.
DTBA1D1
Not in Commercial Distribution

  • 00643169007246 ()


  • Cardiac resynchronization therapy implantable defibrillator

Viva™ XT CRT-D - 00643169007239

CRT-D DTBA1D4 VIVA XT US IS1/DF4
MEDTRONIC, INC.
DTBA1D4
Not in Commercial Distribution

  • 00643169007239 ()


  • Cardiac resynchronization therapy implantable defibrillator

Viva™ S CRT-D - 00643169007185

CRT-D DTBB1D1 VIVA S US IS1/DF1
MEDTRONIC, INC.
DTBB1D1
In Commercial Distribution

  • 00643169007185 ()


  • Cardiac resynchronization therapy implantable defibrillator

metra Liver Perfusion Circuit Pack - 05060462240043

The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours. The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macro steatosis less than or equal to 15 percent, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
ORGANOX LIMITED
D0146_US
In Commercial Distribution

  • 05060462240043 ()


  • Liver donor-organ preservation/transport system

OrganOx metra - 05060462240029

The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours. The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macrosteatosis less than or equal to 15%, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
ORGANOX LIMITED
D0146
In Commercial Distribution

  • 05060462240029 ()


  • Liver donor-organ preservation/transport system

Evera MRI™ XT VR SureScan® - 00643169314153

ICD DVMB1D4 EVERA MRI VR XT DF4 US
MEDTRONIC, INC.
DVMB1D4
In Commercial Distribution

  • 00643169314153 ()


  • Single-chamber implantable defibrillator

Evera MRI™ S DR SureScan® - 00643169314139

ICD DDMC3D4 EVERA MRI DR S DF4 US
MEDTRONIC, INC.
DDMC3D4
Not in Commercial Distribution

  • 00643169314139 ()


  • Dual-chamber implantable defibrillator
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