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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Joint finder
OMNIA MEDICAL, LLC
11-5P-JFR1
In Commercial Distribution

  • 00843511121228 ()
11-5P-JFR1

  • Orthopaedic chisel
EDTA SOLUTION 17% 32OZ 1P
Peter Brasseler Holdings, LLC
5028445U0
In Commercial Distribution

  • 00887919884729 ()


  • Root canal cleaning solution
ARK™ Methotrexate II Dilution Buffer is intended for dilution of specimens containing high concentrations of methotrexate for the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0004-00
In Commercial Distribution

  • 00812101031223 ()
5071-0004-00

  • Methotrexate therapeutic drug monitoring IVD, calibrator
ARK™ Methotrexate II Control is intended for use in quality control of the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0003-02
In Commercial Distribution

  • 00812101031216 ()
5071-0003-02

  • Methotrexate therapeutic drug monitoring IVD, control
ARK™ Methotrexate II Control is intended for use in quality control of the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0003-00
In Commercial Distribution

  • 00812101031193 ()
5071-0003-00

  • Methotrexate therapeutic drug monitoring IVD, control
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)
ARC Adjustable Radial Cuff- Small
Tz Medical, Inc.
RCB-0047
In Commercial Distribution

  • 00811331011333 ()
  • 00811331011500 ()


  • Radial artery compression device
ARC Adjustable Radial Cuff- Large
Tz Medical, Inc.
RCB-0049
In Commercial Distribution

  • 00811331011470 ()
  • 00811331011487 ()


  • Radial artery compression device
Biotronik Neptune Pad
Tz Medical, Inc.
8870-02
In Commercial Distribution

  • 00811331011456 ()
  • 00811331011463 ()


  • Wound compression dressing
ARC Adjustable Radial Cuff- Medium
Tz Medical, Inc.
RCB-0048
In Commercial Distribution

  • 00811331011333 ()
  • 00811331011340 ()


  • Radial artery compression device
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