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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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Manus Medical, LLC
D36-8931
In Commercial Distribution

  • 20811870030257 ()
  • 00811870030253 ()


  • General surgical procedure kit, non-medicated, single-use
Measurement of Hydrogen, Methane and Oxygen levels in the exhaled breath.
BEDFONT SCIENTIFIC LIMITED
GastroCHECK
In Commercial Distribution

  • 05060246860375 ()
GASTROCEHCK-US

  • Ambient gas analyser
Measurement of Hydrogen, Methane and Oxygen levels in the exhaled breath.
BEDFONT SCIENTIFIC LIMITED
GastroCHECK
In Commercial Distribution

  • 05060246860368 ()
GASTROCHECK

  • Ambient gas analyser
Cassette Printer
SAKURA FINETEK U.S.A., INC.
9022
In Commercial Distribution

  • 00615233012494 ()
9022

  • Computed radiography digital imaging scanner
PATHFINDER 350D PLUS DECAPPER DOUBLE SORTER, 12-16MM OD TUBES
AIM LAB AUTOMATION TECHNOLOGIES PTY LTD
PS-U-A711
In Commercial Distribution

  • 09356119002413 ()
06R6302

  • Specimen processing instrument IVD
PATHFINDER 350D DECAPPER SORTER, 12-16MM OD TUBES
AIM LAB AUTOMATION TECHNOLOGIES PTY LTD
PS-U-A710
In Commercial Distribution

  • 09356119002406 ()
06R6301

  • Specimen processing instrument IVD
PATHFINDER 350A ARCHIVER FOR ABBOTT ARCHITECT RACK
AIM LAB AUTOMATION TECHNOLOGIES PTY LTD
PS-U-A084
In Commercial Distribution

  • 09356119002222 ()
04Z7303

  • Specimen processing instrument IVD
PATHFINDER 350A-HC ARCHIVER, HIGH CAPACITY, ONLY FOR 12-13MM OD TUBES
AIM LAB AUTOMATION TECHNOLOGIES PTY LTD
PS-U-A069
In Commercial Distribution

  • 09356119002215 ()
04Z7302

  • Specimen processing instrument IVD
PATHFINDER 350A ARCHIVER, 12-16MM OD TUBES
AIM LAB AUTOMATION TECHNOLOGIES PTY LTD
PS-U-A070
In Commercial Distribution

  • 09356119002208 ()
04Z7301

  • Specimen processing instrument IVD
PATHFINDER 450S SORTER, 6 POSITIONS
AIM LAB AUTOMATION TECHNOLOGIES PTY LTD
PS-U-A605
In Commercial Distribution

  • 09356119002000 ()
06R6001

  • Specimen processing instrument IVD
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