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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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Disposable Mouth Mirrors
Premium Plus International Limited
N800-BLUE
In Commercial Distribution

  • D838N800BLUE8 ()
  • D838N800BLUE6 ()
  • D838N800BLUE2 ()
  • D838N800BLUE0 ()


  • Dental mirror, reusable
3-IN-1 TRAYS
Premium Plus International Limited
N405
In Commercial Distribution

  • D838N4058 ()
  • D838N4056 ()
  • D838N4052 ()
  • D838N4050 ()


  • Dental impression tray, single-use
3-IN-1 TRAYS
Premium Plus International Limited
N404
In Commercial Distribution

  • D838N4048 ()
  • D838N4046 ()
  • D838N4042 ()
  • D838N4040 ()


  • Dental impression tray, single-use
3-IN-1 TRAYS
Premium Plus International Limited
N403
In Commercial Distribution

  • D838N4038 ()
  • D838N4036 ()
  • D838N4032 ()
  • D838N4030 ()


  • Dental impression tray, single-use
3-IN-1 TRAYS
Premium Plus International Limited
N402
In Commercial Distribution

  • D838N4028 ()
  • D838N4026 ()
  • D838N4022 ()
  • D838N4020 ()


  • Dental impression tray, single-use
3-IN-1 TRAYS
Premium Plus International Limited
N401
In Commercial Distribution

  • D838N4018 ()
  • D838N4016 ()
  • D838N4012 ()
  • D838N4010 ()


  • Dental impression tray, single-use
PROPHY CUPS
Premium Plus International Limited
M222YL
In Commercial Distribution

  • D838M222YL8 ()
  • D838M222YL6 ()
  • D838M222YL2 ()
  • D838M222YL0 ()


  • Dental polishing cup, single-use
PROPHY CUPS
Premium Plus International Limited
M222XA
In Commercial Distribution

  • D838M222XA8 ()
  • D838M222XA6 ()
  • D838M222XA2 ()
  • D838M222XA0 ()


  • Dental polishing cup, single-use
PROPHY CUPS
Premium Plus International Limited
M222WT
In Commercial Distribution

  • D838M222WT8 ()
  • D838M222WT6 ()
  • D838M222WT2 ()
  • D838M222WT0 ()


  • Dental polishing cup, single-use
PROPHY CUPS
Premium Plus International Limited
M222SA
In Commercial Distribution

  • D838M222SA8 ()
  • D838M222SA6 ()
  • D838M222SA2 ()
  • D838M222SA0 ()


  • Dental polishing cup, single-use
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