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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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ANTIFUNGALS LEVEL 2
UTAK LABORATORIES, INC.
A-FUNG L2 S F MAYO
In Commercial Distribution

  • B800AFUNGL2SFMAYO5 ()
  • B800AFUNGL2SFMAYO0 ()

  • Total Volume: 0.5 Milliliter
A-FUNG L2 S F MAYO

  • Multiple-therapy therapeutic drug monitoring IVD, control
ACETAMINOPHEN PLUS 2
UTAK LABORATORIES, INC.
ACETA+ V3 2 S F BD
In Commercial Distribution

  • B800ACETAV32SFBD5 ()
  • B800ACETAV32SFBD0 ()

  • Total Volume: 4 Milliliter
ACETA+ V3 2 S F BD

  • Multiple drugs of abuse IVD, control
Lead Level 2
UTAK LABORATORIES, INC.
93312
In Commercial Distribution

  • B800933125 ()
  • B800933120 ()

  • Total Volume: 3 Milliliter
93312

  • Lead IVD, control
DAU HC 2
UTAK LABORATORIES, INC.
50701
In Commercial Distribution

  • B800507015 ()
  • B800507010 ()

  • Total Volume: 10 Milliliter
50701

  • Multiple drugs of abuse IVD, control
DAU IA 2
UTAK LABORATORIES, INC.
50601
In Commercial Distribution

  • B800506015 ()
  • B800506010 ()

  • Total Volume: 10 Milliliter
50601

  • Multiple drugs of abuse IVD, control
Metals Level 2
UTAK LABORATORIES, INC.
44522
In Commercial Distribution

  • B800445225 ()
  • B800445220 ()

  • Total Volume: 3 Milliliter
44522

  • Multiple heavy metal IVD, control
Antifungals Level 2
UTAK LABORATORIES, INC.
43011
In Commercial Distribution

  • B800430115 ()
  • B800430110 ()

  • Total Volume: 5 Milliliter
43011

  • Multiple antifungal therapeutic drug monitoring IVD, control
Immunosuppressants Level 2
UTAK LABORATORIES, INC.
41631
In Commercial Distribution

  • B800416315 ()
  • B800416310 ()

  • Total Volume: 3 Milliliter
41631

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control
DEXAMETHASONE LEVEL 2
UTAK LABORATORIES, INC.
20198
In Commercial Distribution

  • B800201985 ()
  • B800201980 ()

  • Total Volume: 3 Milliliter
20198

  • Multiple steroid hormone IVD, control
Methotrexate Level 2
UTAK LABORATORIES, INC.
12104
In Commercial Distribution

  • B800121045 ()
  • B800121040 ()

  • Total Volume: 5 Milliliter
12104

  • Methotrexate therapeutic drug monitoring IVD, control
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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