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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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The ARK™ Methotrexate II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5071-0001-01
In Commercial Distribution

  • 00812101031179 ()
5071-0001-01

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
The ARK Methotrexate Assay c-Pack (cobas c pack green reagent packs) is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5026-0001-03
In Commercial Distribution

  • 00812101030639 ()
5026-0001-03

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
2% CHLORHEXIDINE GLUCONATE
Peter Brasseler Holdings, LLC
5026553U0
In Commercial Distribution

  • 00887919807254 ()


  • Root canal cleaning solution
Resorbable Borate Glass Wound Management Device
ETS Wound Care LLC
MSG-0202
In Commercial Distribution

  • 00812005030421 ()


  • Synthetic wound matrix dressing
Resorbable Borate Glass Wound Management Device
ETS Wound Care LLC
MSG-0106
In Commercial Distribution

  • 00812005030339 ()
  • 00812005030322 ()


  • Synthetic wound matrix dressing
Resorbable Borate Glass Wound Management Device
ETS Wound Care LLC
MWM-0101
In Commercial Distribution

  • 00812005030292 ()
  • 00812005030285 ()


  • Synthetic wound matrix dressing
Resorbable Borate Glass Wound Management Device
ETS Wound Care LLC
MWM-0202
In Commercial Distribution

  • 00812005030230 ()
  • 00812005030223 ()


  • Synthetic wound matrix dressing
Resorbable Borate Glass Wound Management Device
ETS Wound Care LLC
MES-0101
Not in Commercial Distribution

  • 00812005030117 ()
  • 00812005030087 ()


  • Synthetic wound matrix dressing
Resorbable Borate Glass Wound Management Device
ETS Wound Care LLC
MET-0101
Not in Commercial Distribution

  • 00812005030056 ()
  • 00812005030025 ()


  • Synthetic wound matrix dressing
ENDOSYNC A.I.1P
Peter Brasseler Holdings, LLC
5025412RF
In Commercial Distribution

  • 00887919769118 ()


  • Endodontic apex locator
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