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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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Medegen Medical Products - 00700812016427

7QT. Wash Basin Gold 50/cs 24/plt
MEDEGEN MEDICAL PRODUCTS, LLC
541-5078-0000
In Commercial Distribution

  • 10700812016424 ()
  • 00700812016427 ()
541-5078-0000

  • Washbowl, reusable

eSensor® XT-8 - 00857167005245

eSensor® Warfarin Sensitivity Test Amplification Reagents (24)
GENMARK DIAGNOSTICS, INC.
Warfarin Sensitivity Test (WST)
Not in Commercial Distribution

  • 00857167005245 ()
MT002001

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex

eSensor® XT-8 - 00857167005153

eSensor® Cystic Fibrosis (CF) Genotyping Test (24)
GENMARK DIAGNOSTICS, INC.
eSensor® Cystic Fibrosis (CF)
Not in Commercial Distribution

  • 00857167005153 ()
MT002015

  • Cystic fibrosis IVD, kit, multiplex

eSensor® XT-8 - 00857167005061

eSensor® Warfarin Sensitivity Test Cartridges (WST) (24)
GENMARK DIAGNOSTICS, INC.
Warfarin Sensitivity Test (WST)
Not in Commercial Distribution

  • 00857167005061 ()
MT002000

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex

HIgH-Flo™ Needle Set - 00659443000612

24 Gauge Needle Sets - 3 needles - 6 mm
REPRO MED SYSTEMS, INC.
RMS32406
In Commercial Distribution

  • 10659443000619 ()
  • 00659443000612 ()

  • Needle Gauge: 24 Gauge
RMS32406

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000605

24 Gauge Needle Sets - 2 needles - 14 mm
REPRO MED SYSTEMS, INC.
RMS22414
In Commercial Distribution

  • 10659443000602 ()
  • 00659443000605 ()

  • Needle Gauge: 24 Gauge
RMS22414

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000599

24 Gauge Needle Sets - 2 needles - 12 mm
REPRO MED SYSTEMS, INC.
RMS22412
In Commercial Distribution

  • 10659443000596 ()
  • 00659443000599 ()

  • Needle Gauge: 24 Gauge
RMS22412

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000582

24 Gauge Needle Sets - 2 needles - 9 mm
REPRO MED SYSTEMS, INC.
RMS22409
In Commercial Distribution

  • 10659443000589 ()
  • 00659443000582 ()

  • Needle Gauge: 24 Gauge
RMS22409

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000575

24 Gauge Needle Sets - 2 needles - 6 mm
REPRO MED SYSTEMS, INC.
RMS22406
In Commercial Distribution

  • 10659443000572 ()
  • 00659443000575 ()

  • Needle Gauge: 24 Gauge
RMS22406

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000568

24 Gauge Needle Sets - 1 needle - 14 mm
REPRO MED SYSTEMS, INC.
RMS12414
In Commercial Distribution

  • 10659443000565 ()
  • 00659443000568 ()

  • Needle Gauge: 24 Gauge
RMS12414

  • Subcutaneous infusion/injection port needle
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