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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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No Description
UTAK LABORATORIES, INC.
430805C08
In Commercial Distribution

  • B80003716500020 ()
  • B80003716500021 ()
  • B80003716500022 ()
  • B80003716500023 ()
  • B80003716500026 ()
  • B80003716500027 ()
  • B80003716500028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
VLGR 2 S F MAYO
In Commercial Distribution

  • B80002509000060 ()
  • B80002509000061 ()
  • B80002509000062 ()
  • B80002509000063 ()
  • B80002509000066 ()
  • B80002509000067 ()
  • B80002509000068 ()
  • B80002509000069 ()


  • Multiple-therapy therapeutic drug monitoring IVD, control
IMMUNOSUPPRESSANTS QC 2
UTAK LABORATORIES, INC.
025090-0002
In Commercial Distribution

  • B80002509000020 ()
  • B80002509000023 ()

  • Total Volume: 10 Milliliter
IMMU 2 MAYO V2

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control
No Description
Dynatronics Corporation
7B0284
Not in Commercial Distribution

  • 10660584000680 ()

  • Area/Surface Area: 8 Square inch


  • Transcutaneous electrical stimulation electrode, single-use
No Description
Dynatronics Corporation
7B0283
Not in Commercial Distribution

  • 10660584000673 ()

  • Area/Surface Area: 4 Square inch


  • Transcutaneous electrical stimulation electrode, single-use
No Description
Dynatronics Corporation
7B0281
Not in Commercial Distribution

  • 10660584000659 ()

  • Area/Surface Area: 3.14 Square inch


  • Transcutaneous electrical stimulation electrode, single-use
No Description
Dynatronics Corporation
DF1.25R
In Commercial Distribution

  • 10660584000628 ()

  • Area/Surface Area: 7.00 Square inch


  • Transcutaneous electrical stimulation electrode, single-use
No Description
Dynatronics Corporation
DF2x2
In Commercial Distribution

  • 10660584000604 ()

  • Area/Surface Area: 3.14 Square inch


  • Transcutaneous electrical stimulation electrode, single-use
No Description
Dynatronics Corporation
DF2R
In Commercial Distribution

  • 10660584000581 ()

  • Area/Surface Area: 3.14 Square inch


  • Transcutaneous electrical stimulation electrode, single-use
INSTRUMENTATION TRAY - LID ROMEO2®
SpineArt SA
ROM-BX 10 02-N
In Commercial Distribution

  • 07640450866622 ()
ROM-BX 10 02-N

  • Instrument tray, reusable
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