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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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3M™ Red Dot™ ECG Resting Electrodes, 2360, 0.8 in x 0.8 in (2 cm x 2 cm), 100/Bag, 40 Bag/Case
3M COMPANY
2360
In Commercial Distribution

  • 00707387817220 ()
  • 10707387817227 ()
2360

  • Electrocardiographic electrode, single-use
An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic patients.
NANO-DITECH CORPORATION
TF8147
In Commercial Distribution

  • 00895160002526 ()
  • 10895160002523 ()
TF8147

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
Fluorescence in vitro diagnostic test kit for the detection of cardiac troponin I in human while blood, serum and plasma of myocardial infarction patients
NANO-DITECH CORPORATION
TF3151
In Commercial Distribution

  • 00895160002410 ()
  • 10895160002417 ()
TF3151

  • Troponin I IVD, kit, fluorescent immunoassay
Assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range.
Affinity Biologicals Inc
LFGCP0181
In Commercial Distribution

  • 10629009031814 ()
  • 10629009030015 ()
  • 16290090031812 ()


  • Multiple coagulation factor IVD, control
Assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range.
Affinity Biologicals Inc
LFGCP0125
In Commercial Distribution

  • 10629009031258 ()
  • 10629009030015 ()
  • 16290090031256 ()


  • Multiple coagulation factor IVD, control
Assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range.
Affinity Biologicals Inc
LFGCP0105
In Commercial Distribution

  • 10629009031050 ()
  • 10629009030015 ()
  • 16290090031058 ()


  • Multiple coagulation factor IVD, control
3M™ Steri-Drape™ Incise Drape, 1051, Incise Area 60 cm x 85 cm (23 in x 33 in), 10/Carton, 4 Cartons/Case
3M COMPANY
1051
In Commercial Distribution

  • 50707387793024 ()
  • 30707387793020 ()
  • 10707387793026 ()
1051

  • Patient surgical drape, single-use
Sterile IODINE—125 source for interstitial Brachytherapy for use with seedSelectron®. Quantity in package is customer order specific in range 10 – 100 seeds.
Nucletron B.V.
130002-01
Not in Commercial Distribution

  • 98717213037833 ()
  • 08717213038066 ()
130002

  • Remote-afterloading brachytherapy source
Metallic bag with 454 gr and plastic bottle To take dental impressions in which fine details can be reproduced, existing in the oral cavity.
MDC DENTAL
Max Print Cromático
In Commercial Distribution

  • 07506338301053 ()


  • Alginate dental impression material
Glucose Oxidase Reagent is for the quantitative determination of Glucose in serum on Hitachi analyzers. For in vitro diagnostic use only. 12 x 67ml
POINTE SCIENTIFIC, INC.
HG921-804
In Commercial Distribution

  • 00811727013033 ()
HG921-804

  • Glucose IVD, kit, spectrophotometry
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