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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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Trulife - 00645517185781

SOPHIA GRAY 34-A/B ACTIVITY MASTECTOM BRA G330B34
Trulife Limited
G330B34
In Commercial Distribution

  • 00645517185781 ()


  • Postsurgical brassiere, non-antimicrobial

Trinity Biotech - 05391516748100

Hemoglobin A1c assay, Premier Buffer B Reagent - 3.8L
PRIMUS CORPORATION
Premier Buffer B Reagent - 3.8L
In Commercial Distribution

  • 05391516748100 ()

  • Total Volume: 3.8 Liter
01-03-0081

  • Glycated haemoglobin (HbA1c) IVD, reagent

Trinity Biotech - 05391516747684

B. burgdorferi WB Weakly Reactive IgM Control,120µL
MARDX DIAGNOSTICS, INC.
40-2029L
In Commercial Distribution

  • 05391516747684 ()
40-2029L

  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, control

Trinity Biotech - 05391516747677

B. burgdorferi WB IgM Serum Band Locator, 250µL
MARDX DIAGNOSTICS, INC.
40-2022L
In Commercial Distribution

  • 05391516747677 ()
40-2022L

  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, control

Trinity Biotech - 05391516747622

B. burgdorferi WB IgG Serum Band Locator, 250µL
MARDX DIAGNOSTICS, INC.
40-2023L
In Commercial Distribution

  • 05391516747622 ()
40-2023L

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516747608

B. burgdorferi 10 Well Slides, 10 each pack
MARDX DIAGNOSTICS, INC.
32-5010
In Commercial Distribution

  • 05391516747608 ()
32-5010

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516744775

Hemoglobin A1c assay, Premier Buffer B Reagent - 940mL
PRIMUS CORPORATION
Premier Buffer B Reagent - 940mL
In Commercial Distribution

  • 05391516744775 ()

  • Total Volume: 940 Milliliter
01-03-0096

  • Glycated haemoglobin (HbA1c) IVD, reagent

Trinity Biotech - 05391516744171

Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 3.8L
PRIMUS CORPORATION
Ultra2 Buffer B Reagent - 3.8L
In Commercial Distribution

  • 05391516744171 ()

  • Total Volume: 3.8 Liter
01-03-0012

  • Glycated haemoglobin (HbA1c) IVD, reagent

Trinity Biotech - 05391516744164

Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 940mL
PRIMUS CORPORATION
Ultra2 Buffer B Reagent - 940mL
In Commercial Distribution

  • 05391516744164 ()

  • Total Volume: 940 Milliliter
01-03-0011

  • Glycated haemoglobin (HbA1c) IVD, reagent

ALLEN - 00615521017712

Astrus Elite 4", Skytron Ctrd a/b pad
HILL-ROM, INC.
900113
In Commercial Distribution

  • 00615521017712 ()
H-403-05-960

  • Operating table mattress, basic
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