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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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IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
424537
In Commercial Distribution

  • 00815381020727 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
MONOBIND, INC.
7375-300
In Commercial Distribution

  • 00816870022468 ()

  • Width: 7.75 Inch
7375-300B

  • C-peptide IVD, kit, chemiluminescent immunoassay
No Description
MONOBIND, INC.
7375-300
In Commercial Distribution

  • 00816870022451 ()

  • Width: 7.75 Inch
7375-300A

  • C-peptide IVD, kit, chemiluminescent immunoassay
No Description
MONOBIND, INC.
7325-300
In Commercial Distribution

  • 00816870020778 ()

  • Width: 7.75 Inch
7325-300A

  • C-peptide IVD, kit, enzyme immunoassay (EIA)
The Discovery RF180 is a floor-mounted radiographic, fluoroscopic and linear tomographic system that consists of a 90/90 universal remote-controlled table with variable height, an R&F panel connected to a digital system and a voltage generator.
GENERAL MEDICAL MERATE SPA
Discovery RF180
In Commercial Distribution

  • 08054890480109 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
The CLISIS SYSTEMS is a floor-mounted radiographic, fluoroscopic and linear tomographic system that consists of a 90/90 universal remote-controlled table with variable height, an R&F panel connected to a digital system and a voltage generator.
GENERAL MEDICAL MERATE SPA
CLISIS SYSTEMS
In Commercial Distribution

  • 08054890480055 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
Xpert Flu kit; 10 test kit
CEPHEID
GXFLU-10A
Not in Commercial Distribution

  • 07332940001070 ()
GXFLU-10A

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The HarmonyAIR Hybrid High Definition Single Light, with Dual Flat Panel Monitor, No Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176044 ()
LEH56INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Hybrid High Definition Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176037 ()
LEH56IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Hybrid High Definition Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176020 ()
LEH56IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
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