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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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Fixture Φ3.2/L14.5
Achimhai Medical Corporation
I3215M
In Commercial Distribution

  • 08800024913698 ()
I3215M

  • Screw endosteal dental implant, two-piece
Fixture Φ3.2/L8.0
Achimhai Medical Corporation
I3208M
In Commercial Distribution

  • 08800024913650 ()
I3208M

  • Screw endosteal dental implant, two-piece
Fixture Φ3.2/L9.5
Achimhai Medical Corporation
I3210
In Commercial Distribution

  • 08800024913612 ()
I3210

  • Screw endosteal dental implant, two-piece
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Controls
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199943
In Commercial Distribution

  • 10758750033560 ()
6199943

  • SARS-CoV-2 antigen IVD, control
VITROS Immunodiagnostic Products BRAHMS PCT Calibrator
ORTHO CLINICAL DIAGNOSTICS
6195575
In Commercial Distribution

  • 10758750033294 ()
  • 20758750033291 ()
6195575

  • Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products HIV Combo Controls (HIV p24 Antigen)
ORTHO CLINICAL DIAGNOSTICS
691 2263
In Commercial Distribution

  • 10758750033171 ()
  • 20758750033178 ()
691 2263

  • HIV1 antigen IVD, control
VITROS Immunodiagnostic Products Troponin I ES Range Verifiers
ORTHO CLINICAL DIAGNOSTICS
6802303
In Commercial Distribution

  • 10758750002528 ()
  • 20758750002525 ()
6802303

  • Troponin I IVD, kit, chemiluminescent immunoassay
InteliQ Specialty Immunoassay Plus Control Level Low MiniPak (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
12019558
In Commercial Distribution

  • 03610522354665 ()
12019558

  • Multiple clinical chemistry protein IVD, control
Liquichek Specialty Immunoassay Plus Control Level Low MiniPak (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
12019576
In Commercial Distribution

  • 03610522354658 ()
12019576

  • Multiple clinical chemistry protein IVD, control
Bulk CSF Negative
EXACT DIAGNOSTICS, LLC
12019432
In Commercial Distribution

  • 03610522350773 ()
12019432

  • PCR/NAT negative control IVD
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