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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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SENTINEL 11 HL7 TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522129308 ()
040-1724-01

  • Cardiology information system application software
SENTINEL 11 NETWORKED TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129292 ()
040-1723-01

  • Cardiology information system application software
SENTINEL 11 STANDALONE TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129285 ()
040-1722-01

  • Cardiology information system application software
LIFESCREEN PRO ANALYSER, V1.X
SPACELABS HEALTHCARE (WASHINGTON), INC
Lifescreen Pro
In Commercial Distribution

  • 10841522128837 ()
98800

  • Electrocardiographic long-term ambulatory recording analyser
INSTALLATION KIT, PATHFINDER SL 1.9.2
SPACELABS HEALTHCARE (WASHINGTON), INC
Pathfinder SL
In Commercial Distribution

  • 10841522128820 ()
040-1763-00

  • Electrocardiographic long-term ambulatory recording analyser
Guidewire
GALT MEDICAL CORP.
SGW-011-08
In Commercial Distribution

  • 00841268100541 ()
  • 10841268100548 ()
  • 20841268100545 ()

  • Outer Diameter: 0.035 Inch
SGW-011-08

  • Peripheral vascular guidewire, manual
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
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