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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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SUR-FIT Natura® Drainable Pouch, 14" Tran W/1-Sided Comfort Panel, 4"
CONVATEC, PURCHASING DEPARTMENT
401515
In Commercial Distribution

  • 10768455103376 ()
  • 00768455103379 ()
  • 00768455182541 ()


  • Multiple-piece urostomy bag, open-ended
QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel.
Opgen, Inc.
AC043
Not in Commercial Distribution

  • 20812125010079 ()
AC043

  • Specimen processing instrument IVD
The M5 High Density Dual Package, Single Flat Panel Monitor Mount, Auxiliary Arm Single Flat Panel Monitor, No Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191580 ()
LMH03

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR M5 Dual Package with 2 Single Flat Panel Monitor, without Control, with 2 Flat Panel Monitors and Tandems, is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995172657 ()
LM03NT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
Reagent Red Blood Cells, ALBAcyte Antibody Identification (16-Cell) for tube techniques, 2-3% suspension.
ALBA BIOSCIENCE LIMITED
Z473U
In Commercial Distribution

  • 05060242471384 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Reagent Red Blood Cells, ALBAcyte Expanded Rh Negative Antibody Screen for tube techniques, 2-3% suspension.
ALBA BIOSCIENCE LIMITED
Z464U
In Commercial Distribution

  • 05060242471377 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Reagent Red Blood Cells, ALBAcyte Antibody Identification Cells (papain-treated) for tube techniques, 2-3% suspension.
ALBA BIOSCIENCE LIMITED
Z472U
In Commercial Distribution

  • 05060242471193 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Reagent Red Blood Cells, ALBAcyte Antibody Identification Cells for tube techniques, 2-3% suspension.
ALBA BIOSCIENCE LIMITED
Z471U
In Commercial Distribution

  • 05060242471186 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood group antibodies.
IMMUCOR, INC.
0002383
In Commercial Distribution

  • 10888234002406 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
This product is used in the identification of unexpected red cell blood group antibodies. This product is manufactured as twenty (20) vials of reagent in a set. Reagent red blood cell vials each contain a 2-4% suspension of group O red blood cells prepared in a buffered preservative solution.
IMMUCOR, INC.
0005020
In Commercial Distribution

  • 10888234001843 ()
0005020

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
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