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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S1 600DT Trpl CA 1150 1000 850 3p Norm DY SL-30M, 9P Norm DY SL-30m, Sgl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003529 ()
C16T432351

  • Operating room light
Series 1, 200 DT Triple CA 1150, 1000, 850, 3P SA 30M, 3P SA 30M, Gen2 MH-A
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003222 ()
C12T432331

  • Operating room light
Standard Imaging QA StereoChecker is a daily machine quality assurance checks for the Cyberknife (Accuray, Sunnyvale CA).
STANDARD IMAGING INC.
91349
In Commercial Distribution

  • 00850019946123 ()
91349

  • Accelerator system quality assurance device
GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 450 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044345008
In Commercial Distribution

  • 08426951070848 ()
00044345008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 300 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044330008
In Commercial Distribution

  • 08426951070831 ()
00044330008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 150 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044315008
In Commercial Distribution

  • 08426951070824 ()
00044315008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 75 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044307508
In Commercial Distribution

  • 08426951070817 ()
00044307508

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
BREATHING CIRCUIT SINGLE LIMB SINGLE-USE 90 INCH POLYURETHANE CA/20 Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
ABC1001
In Commercial Distribution

  • 20885632424417 ()
  • 10885632424410 ()


  • Anaesthesia breathing circuit, single-use
REUSABLE GEL PACK SMALL 4.75X6 IN GLYCERINE CA 24 REUSABLE Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
51792
In Commercial Distribution

  • 20885632413916 ()
  • 10885632413919 ()


  • Hot/cold therapy pack, reusable
REUSABLE GEL PACK LARGE 4.5X9 IN GLYCERINE CA 24 REUSABLE Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
51791
In Commercial Distribution

  • 20885632413909 ()
  • 10885632413902 ()


  • Hot/cold therapy pack, reusable
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