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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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60” (1500mm) 300psi Extension Y-Line with Check Valve
COEUR, INC.
C455-2151
In Commercial Distribution

  • M902121516 ()
  • M902121515 ()
  • M902121510 ()

  • Length: 60 Inch
C455-2151

  • Radiographic procedure tubing
60” (1500mm) 330psi Extension Line
COEUR, INC.
C455-1500
In Commercial Distribution

  • M902115006 ()
  • M902115005 ()
  • M902115000 ()

  • Length: 60 Inch
C455-1500

  • Radiographic procedure tubing
8” Fill Tube
COEUR, INC.
C455-0904
In Commercial Distribution

  • M902109046 ()
  • M902109045 ()
  • M902109040 ()

  • Length: 8 Inch
C455-0904

  • Radiographic procedure tubing
60” (1500mm) 330psi Coiled Connector Tube
COEUR, INC.
C455-0060
In Commercial Distribution

  • M902100606 ()
  • M902100605 ()
  • M902100600 ()

  • Length: 60 Inch
C455-0060

  • Radiographic procedure tubing
QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus.
LUMIQUICK DIAGNOSTICS, INC.
71108B
In Commercial Distribution

  • M90171108B1 ()
  • M90171108B0 ()
  • M90171108B2 ()

  • Length: 80 Millimeter
71108B

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
No Description
BIOTEX, INC.
SL-12
In Commercial Distribution

  • M710SL122 ()
  • M710SL120 ()
  • M710SL124 ()
SL-12

  • Operating room light
The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 235 cm.
SLATER ENDOSCOPY LLC
ES26235
In Commercial Distribution

  • M707ES26235 ()
  • M707ES262351 ()
  • M707ES262350 ()

  • Length: 235 Centimeter
  • Outer Diameter: 2.6 Millimeter
ES26235

  • Flexible endoscopic scissors, single-use
The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 165 cm.
SLATER ENDOSCOPY LLC
ES26165
In Commercial Distribution

  • M707ES26165 ()
  • M707ES261651 ()
  • M707ES261650 ()

  • Length: 165 Centimeter
  • Outer Diameter: 2.6 Millimeter
ES26165

  • Flexible endoscopic scissors, single-use
SYRINGE CONVENIENCE PACK-1CC L/L
STRADIS MEDICAL LLC
TM.SCP1ML
In Commercial Distribution

  • M752TMSCP1ML5 ()
  • M752TMSCP1ML0 ()
  • M752TMSCP1ML1 ()


  • General-purpose syringe, single-use
FLUID FILTER TRANSFER KIT
STRADIS MEDICAL LLC
TM.FFTK
In Commercial Distribution

  • M752TMFFTK5 ()
  • M752TMFFTK0 ()
  • M752TMFFTK1 ()


  • Fluid transfer set, general-purpose
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