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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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50mL Disposable Syringe
COEUR, INC.
C855-5050
In Commercial Distribution

  • M902550506 ()
  • M902550505 ()
  • M902550500 ()

  • Total Volume: 50 Milliliter
C855-5050

  • Angiographic syringe
1200 PSI High Pressure Y-Line with Rotating Adapter
COEUR, INC.
C453-2420
In Commercial Distribution

  • M902124206 ()
  • M902124205 ()
  • M902124200 ()
C453-2420

  • Radiographic procedure tubing
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
ACETONE BLANK
UTAK LABORATORIES, INC.
ACE BLK S F BSRHS
In Commercial Distribution

  • B800ACEBLKSFBSRHS5 ()
  • B800ACEBLKSFBSRHS0 ()
  • B800ACEBLKSFBSRHS55 ()

  • Total Volume: 1 Milliliter
ACE BLK S F BSRHS

  • Multiple-type clinical chemistry analyte profile IVD, control
Post-parturition vaginal retractor intended to retract the vaginal walls following childbirth for improved visualization and access during surgical repair (e.g. suturing) of vaginal tears.
Birch Concepts LLC
1001
In Commercial Distribution

  • B79510011 ()
  • B79510010 ()
  • B79510012 ()
1001

  • Post-parturition vaginal retractor
Patch for use with the SPEAX Communication System
ATAIA INC.
FGN-002
In Commercial Distribution

  • B792FGN003 ()
  • B792FGN002 ()
  • B792FGN012 ()
FGN002

  • Voice amplification system
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