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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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TRIAL 2150320 PLATE TRIAL 20MM
MEDTRONIC SOFAMOR DANEK, INC.
2150320
In Commercial Distribution

  • 00643169523937 ()

  • 20 mm


  • Spinal implant trial
GUIDE 2150220 O51 SCREW GUIDE 20MM
MEDTRONIC SOFAMOR DANEK, INC.
2150220
In Commercial Distribution

  • 00643169524828 ()

  • 20 mm


  • Orthopaedic implantation sleeve, reusable
Uni-Gold™ Recombigen® HIV-1/2
TRINITY BIOTECH PUBLIC LIMITED COMPANY
1206506
Not in Commercial Distribution

  • 05391516746106 ()

  • 20 Tests
1206506

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Oxalate Kit
TRINITY BIOTECH PUBLIC LIMITED COMPANY
591-C
In Commercial Distribution

  • 05391516742238 ()

  • 20 Tests
591-C

  • Oxalate IVD, kit, spectrophotometry
Sample Purifier Tubes
TRINITY BIOTECH PUBLIC LIMITED COMPANY
591-20
In Commercial Distribution

  • 05391516742207 ()
  • 05391516749602 ()

  • 20 Tubes
591-20

  • Oxalate IVD, reagent
HER2 CISH pharmDx Kit
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
SK109
In Commercial Distribution

  • 05700572032960 ()

  • 20 Tests


  • HER2/neu/erbB2 mRNA expression IVD, kit, nucleic acid technique (NAT)
HER2 IQFISH pharmDx™
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
K5731
In Commercial Distribution

  • 05700572032465 ()

  • 20 Tests


  • HER2/neu/erbB2 mRNA expression IVD, kit, nucleic acid technique (NAT)
SureFISH Chr7 CEP 767kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110899G
In Commercial Distribution

  • 05700574033378 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH 21q22.2 ERG 5' BA 552kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110816G
In Commercial Distribution

  • 05700574033361 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH 21q22.13 ERG 3' BA 426kb P20 RD
AGILENT TECHNOLOGIES, INC.
G110802R
In Commercial Distribution

  • 05700574033354 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
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