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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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NEURO EMBOLISM PACK
Cardinal Health 200, LLC
SAN11AN104
In Commercial Distribution

  • 50888439263693 ()
  • 10888439263695 ()
SAN11AN104

  • Embolization implant kit
The Fingertip Pulse Oximeter is non-invasive device intended for spotchecking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate.
EMAY (HK) LIMITED
EMO-80
In Commercial Distribution

  • 04897087200807 ()


  • Pulse oximeter, line-powered
The Fingertip Pulse Oximeter is non-invasive device intended for spotchecking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate
EMAY (HK) LIMITED
EMO-40
In Commercial Distribution

  • 04897087200401 ()


  • Pulse oximeter, line-powered
It's designed for family and individual users to track heart activity at home, at work or on a trip in case of cardiac situation that needs evaluation on the spot.
EMAY (HK) LIMITED
EMG-20
In Commercial Distribution

  • 04897087200203 ()


  • Electrocardiographic monitor
10% Neutral Buffered Formalin
SAKURA FINETEK U.S.A., INC.
5993
In Commercial Distribution

  • 00615233007117 ()
  • 00615233007278 ()
5993

  • 10% Neutral buffered formalin IVD
H&E Stain Kit #1
SAKURA FINETEK U.S.A., INC.
6190
In Commercial Distribution

  • 00615233000040 ()
6190

  • Haematoxylin and eosin (H&E) stain control IVD, kit
anti-IgG Rabbit Monoclonal Antibody [RM116], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8383-C010
In Commercial Distribution

  • 00615233001979 ()
8383-C010

  • Human immunoglobulin G (IgG) rabbit conjugate antibody reagent IVD
anti-IgG Rabbit Monoclonal Antibody [RM116], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8383-M250
In Commercial Distribution

  • 00615233001962 ()
8383-M250

  • Human immunoglobulin G (IgG) rabbit conjugate antibody reagent IVD
anti-Tryptase Rabbit Monoclonal Antibody [EP259], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8372-C010
In Commercial Distribution

  • 00615233001894 ()
8372-C010

  • Tryptase IVD, antibody
anti-Tryptase Rabbit Monoclonal Antibody [EP259], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8372-M250
In Commercial Distribution

  • 00615233001887 ()
8372-M250

  • Tryptase IVD, antibody
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