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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ARK™ Methotrexate II Calibrator is intended for use in calibration of the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0002-00
In Commercial Distribution

  • 00812101031186 ()
5071-0002-00

  • Methotrexate therapeutic drug monitoring IVD, calibrator
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 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
5071-0001-00
In Commercial Distribution

  • 00812101031162 ()
5071-0001-00

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
WIRELE-X TOUCH PROBE 2P
Peter Brasseler Holdings, LLC
5031043U0
In Commercial Distribution

  • 00887919972228 ()


  • Endodontic apex locator
WIRELE-X LIP CLIP 5P
Peter Brasseler Holdings, LLC
5031042U0
In Commercial Distribution

  • 00887919972198 ()


  • Endodontic apex locator
WIRELE-X FILE CLIP 2P
Peter Brasseler Holdings, LLC
5031041U0
In Commercial Distribution

  • 00887919972167 ()


  • Endodontic apex locator
WIRELE-X SWITCH ADAPTER 5V 2A
Peter Brasseler Holdings, LLC
5031040U0
In Commercial Distribution

  • 00887919972136 ()


  • Endodontic apex locator
WIRELE-X MEASUREMENT CABLE
Peter Brasseler Holdings, LLC
5031039U0
In Commercial Distribution

  • 00887919972105 ()


  • Endodontic apex locator
WIRELE-X APEX LOCATOR
Peter Brasseler Holdings, LLC
5030838U0
In Commercial Distribution

  • 00887919972075 ()


  • Endodontic apex locator
VeraPlug Flow Nonsterile Bulk - X-Large
KRISHNA IMPORTS INC
BVF-1004
In Commercial Distribution

  • 00810799030245 ()
  • 00810799030207 ()
BVF-1004

  • Lacrimal punctum plug
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