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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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The Portable X-ray System (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
Osstem Implant Co., Ltd._Gasan Branch
EXARO
In Commercial Distribution

  • 08800000995014 ()


  • Portable basic diagnostic x-ray system, digital
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
Ablation Connection Box
BOSTON SCIENTIFIC CORPORATION
M004RA6301US0
In Commercial Distribution

  • 00191506034429 ()
M004RA6301US0

  • Cardiac mapping system
Ablation Connection Box (for INTELLAGEN™)
BOSTON SCIENTIFIC CORPORATION
M004RA65010
In Commercial Distribution

  • 00191506020804 ()
M004RA65010

  • Cardiac mapping system
Ablation Connection Box - IntellaNav StablePoint™ (for INTELLAGEN™)
BOSTON SCIENTIFIC CORPORATION
M004RA63020
In Commercial Distribution

  • 00191506020798 ()
M004RA63020

  • Cardiac mapping system
No Description
REMEDI CO.,LTD.
ES70
In Commercial Distribution

  • 08800060100243 ()


  • Portable basic diagnostic x-ray system, digital
No Description
REMEDI CO.,LTD.
ES70
In Commercial Distribution

  • 08800060100236 ()


  • Portable basic diagnostic x-ray system, digital
No Description
REMEDI CO.,LTD.
REMEX KA6
In Commercial Distribution

  • 08800060100151 ()


  • Portable basic diagnostic x-ray system, digital
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