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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Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2ENR0
In Commercial Distribution

  • 08714729994077 ()


  • Cardiac mapping system
No Description
BOSTON SCIENTIFIC CORPORATION
H7495554280
In Commercial Distribution

  • 08714729986089 ()
H7495554280

  • Cardiovascular ultrasound imaging system
Ablation Connection Box (SmartAblate)
BOSTON SCIENTIFIC CORPORATION
M004RA64030
In Commercial Distribution

  • 08714729986003 ()


  • Cardiac mapping system
Ablation Connection Box (IBI/Ampere)
BOSTON SCIENTIFIC CORPORATION
M004RA61030
In Commercial Distribution

  • 08714729985983 ()


  • Cardiac mapping system
Mapping System
BOSTON SCIENTIFIC CORPORATION
M004OPLINSTALL2EN0
In Commercial Distribution

  • 00191506055370 ()
M004OPLINSTALL2EN0

  • Cardiac mapping system
Mapping System Signal Station
BOSTON SCIENTIFIC CORPORATION
M004OPAL10200
In Commercial Distribution

  • 00191506055325 ()
M004OPAL10200

  • Cardiac mapping system
Mapping System Workstation PC
BOSTON SCIENTIFIC CORPORATION
M004OPAL40100
In Commercial Distribution

  • 00191506055301 ()
M004OPAL40100

  • Cardiac mapping system
Location Reference Patch Kit
BOSTON SCIENTIFIC CORPORATION
M004RAPATCH20
In Commercial Distribution

  • 00191506000813 ()
M004RAPATCH20

  • Cardiac mapping system reference patch
Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
H749ILAB220CARTR0
In Commercial Distribution

  • 08714729848967 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240INSB0
In Commercial Distribution

  • 08714729848905 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120INSB0
In Commercial Distribution

  • 08714729848899 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120N2710
In Commercial Distribution

  • 08714729847892 ()


  • Cardiovascular ultrasound imaging system
Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120C2710
In Commercial Distribution

  • 08714729847885 ()


  • Cardiovascular ultrasound imaging system
Motordrive Unit
BOSTON SCIENTIFIC CORPORATION
H749MDU5PLUSR0
In Commercial Distribution

  • 08714729842309 ()


  • Cardiovascular ultrasound imaging system
Motordrive Unit
BOSTON SCIENTIFIC CORPORATION
H749MDU5PLUS0
In Commercial Distribution

  • 08714729842279 ()


  • Cardiovascular ultrasound imaging system
Rhythmia Workstation PC
BOSTON SCIENTIFIC CORPORATION
M004RH40000
In Commercial Distribution

  • 08714729842118 ()


  • Cardiac mapping system
Sensor Interface Unit (SIU)
BOSTON SCIENTIFIC CORPORATION
M004RH22000
In Commercial Distribution

  • 08714729842101 ()


  • Electromagnetic surgical navigation device tracking system
System Control Unit (SCU)
BOSTON SCIENTIFIC CORPORATION
M004RH21000
In Commercial Distribution

  • 08714729842095 ()


  • Electromagnetic surgical navigation device tracking system
Localization Generator
BOSTON SCIENTIFIC CORPORATION
M004RH20000
In Commercial Distribution

  • 08714729842088 ()


  • Electromagnetic surgical navigation device tracking system
Foot Switch
BOSTON SCIENTIFIC CORPORATION
M004RH15000
In Commercial Distribution

  • 08714729842057 ()


  • Foot-switch, electrical
ECG Box Out - US AAMI
BOSTON SCIENTIFIC CORPORATION
M004RH14000
In Commercial Distribution

  • 08714729842033 ()


  • Cardiac mapping system
Breakout Box MAP Out
BOSTON SCIENTIFIC CORPORATION
M004RH13000
In Commercial Distribution

  • 08714729842026 ()


  • Cardiac mapping system
Breakout Box B Out
BOSTON SCIENTIFIC CORPORATION
M004RH12500
In Commercial Distribution

  • 08714729842019 ()


  • Cardiac mapping system
Breakout Box B In
BOSTON SCIENTIFIC CORPORATION
M004RH12000
In Commercial Distribution

  • 08714729842002 ()


  • Cardiac mapping system
Breakout Box A Out
BOSTON SCIENTIFIC CORPORATION
M004RH11500
In Commercial Distribution

  • 08714729841999 ()


  • Cardiac mapping system
Breakout Box A In
BOSTON SCIENTIFIC CORPORATION
M004RH11000
In Commercial Distribution

  • 08714729841982 ()


  • Cardiac mapping system
Signal Station Kit
BOSTON SCIENTIFIC CORPORATION
M004RH10000
In Commercial Distribution

  • 08714729841975 ()


  • Transducer signal amplifier
Rhythmia Power Supply
BOSTON SCIENTIFIC CORPORATION
M004RAPWR0
In Commercial Distribution

  • 08714729841906 ()


  • Basic power supply, reusable
Location Reference Patch Kit
BOSTON SCIENTIFIC CORPORATION
M004RAPATCH10
In Commercial Distribution

  • 08714729880851 ()
  • 08714729841890 ()


  • Cardiac mapping system reference patch
Male to Male Tip-Jacks 2-2 Pin
BOSTON SCIENTIFIC CORPORATION
M004RAMMTIPS20
In Commercial Distribution

  • 08714729841883 ()


  • Electrical-only medical device connection cable, single-use
Male to Male Tip-Jacks 16-16 Pin
BOSTON SCIENTIFIC CORPORATION
M004RAMMTIPS160
In Commercial Distribution

  • 08714729841876 ()


  • Electrical-only medical device connection cable, single-use
Location Reference Cable
BOSTON SCIENTIFIC CORPORATION
M004RALRCBL10
In Commercial Distribution

  • 08714729841869 ()


  • Electrical-only medical device connection cable, single-use
Conditioning Box
BOSTON SCIENTIFIC CORPORATION
M004RACONDITION0
In Commercial Distribution

  • 08714729841838 ()


  • Cardiac mapping system
Localization Unit Data Cable
BOSTON SCIENTIFIC CORPORATION
M004RA72000
In Commercial Distribution

  • 08714729841791 ()


  • Electrical-only medical device connection cable, single-use
Sensor Interface Unit (SIU) Split Cable
BOSTON SCIENTIFIC CORPORATION
M004RA70000
In Commercial Distribution

  • 08714729841777 ()


  • Electrical-only medical device connection cable, single-use
Connection Box - Maestro™
BOSTON SCIENTIFIC CORPORATION
M004RA62000
In Commercial Distribution

  • 08714729841760 ()


  • Cardiac mapping system
Connection Box - IBI™
BOSTON SCIENTIFIC CORPORATION
M004RA61000
In Commercial Distribution

  • 08714729841753 ()


  • Cardiac mapping system
Connection Box - Stockert™
BOSTON SCIENTIFIC CORPORATION
M004RA60000
In Commercial Distribution

  • 08714729841746 ()


  • Cardiac mapping system
ECG Cable - Chest - US AAMI
BOSTON SCIENTIFIC CORPORATION
M004RA5200US0
In Commercial Distribution

  • 08714729841739 ()


  • Electrocardiographic lead set, reusable
ECG Cable - Limbs - US AAMI
BOSTON SCIENTIFIC CORPORATION
M004RA5100US0
In Commercial Distribution

  • 08714729841715 ()


  • Electrocardiographic lead set, reusable
ECG Cable - Trunk - US AAMI
BOSTON SCIENTIFIC CORPORATION
M004RA5000US0
In Commercial Distribution

  • 08714729841692 ()


  • Electrocardiographic lead set, reusable
Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120CARTB0
In Commercial Distribution

  • 08714729838708 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
M004EPIL240INS0
In Commercial Distribution

  • 08714729810230 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
M004EPIL220INS0
In Commercial Distribution

  • 08714729810223 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB220INS0
In Commercial Distribution

  • 08714729810216 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
M004EPIL120INS0
In Commercial Distribution

  • 08714729810193 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120INS0
In Commercial Distribution

  • 08714729810186 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
M004EPIL100INS0
In Commercial Distribution

  • 08714729810179 ()


  • Cardiovascular ultrasound imaging system
Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240CARTR0
In Commercial Distribution

  • 08714729810155 ()


  • Cardiovascular ultrasound imaging system
Cart Demo System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240CARTD0
In Commercial Distribution

  • 08714729810148 ()


  • Cardiovascular ultrasound imaging system
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