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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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CARBOHYDRATE DEF TRANSFERRIN BY MINICAP CE
SEBIA
2208
In Commercial Distribution

  • 03607360022085 ()
2208

  • Transferrin/transferrin isoform IVD, kit, electrophoresis
PROTEIN SEPERATION BY MINICAP
SEBIA
2203
In Commercial Distribution

  • 03607360022030 ()
2203

  • Protein electrophoresis IVD, kit, electrophoresis
CAPILLARYS /MINICAP WASH SOLUTION IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K082085.
SEBIA
2052
In Commercial Distribution

  • 03607360020524 ()
2052

  • Wash/cleaning solution IVD, automated/semi-automated system
CARBOHYDRATE DEF TRANSFERRIN BY CE MAXI KIT
SEBIA
2029
In Commercial Distribution

  • 03607360020296 ()
2029

  • Transferrin/transferrin isoform IVD, kit, electrophoresis
CARBOHYDRATE DEF TRANSFERRING BY CE
SEBIA
2009
In Commercial Distribution

  • 03607360020098 ()
2009

  • Transferrin/transferrin isoform IVD, kit, electrophoresis
PROTEIN SEPARATION USING CAPILLARY ELECTROPHORESIS
SEBIA
2003
In Commercial Distribution

  • 03607360020036 ()
2003

  • Protein electrophoresis IVD, kit, electrophoresis
Deluxe Dressing Change Kit W/Zpad
ACCESS SCIENTIFIC, LLC
Deluxe Dressing Change kit w/ Zpad
In Commercial Distribution

  • 20859821006456 ()
  • 10859821006459 ()
71751

  • Wearable percutaneous catheter/tube holder
PICC WAND Max Barrier Kit 6Fr
ACCESS SCIENTIFIC, LLC
Max Barrier Kit 6Fr
In Commercial Distribution

  • 20859821006418 ()
  • 10859821006411 ()

  • Length: 7.25 Centimeter
  • Catheter Gauge: 6 French
71878

  • Vascular catheter introduction set, nonimplantable
PICC WAND Max Barrier Kit 5Fr
ACCESS SCIENTIFIC, LLC
Max Barrier Kit 5Fr
In Commercial Distribution

  • 20859821006401 ()
  • 10859821006404 ()

  • Length: 7.25 Centimeter
  • Catheter Gauge: 5 French
71876

  • Vascular catheter introduction set, nonimplantable
PICC WAND Max Barrier Kit 4Fr
ACCESS SCIENTIFIC, LLC
Max Barrier Kit 4Fr
In Commercial Distribution

  • 20859821006395 ()
  • 10859821006398 ()

  • Length: 7.25 Centimeter
  • Catheter Gauge: 4 French
71877

  • Vascular catheter introduction set, nonimplantable
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