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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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CLIAWAIVED INC - 00183278000436

CoronaChek COVID-19 IgG/IgM Rapid Test Cassette (25 per pk) includes 25 droppers, 1 buffer, 1 insert, 1 procedure card)
Cliawaived, Inc.
CLIA-INGM-MC42
In Commercial Distribution

  • 00183278000436 ()
CLIA-INGM-MC42

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
  • SARS-CoV-1 immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical

i-STAT - 10054749000118

G CARTRIDGE
ABBOTT POINT OF CARE INC.
03P83-25
In Commercial Distribution

  • 10054749000118 ()
  • 00054749000111 ()
03P83-25

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Medline Industries, Inc. - 10889942333790

G PACK
MEDLINE INDUSTRIES, INC.
DYNJ48708C
In Commercial Distribution

  • 10889942333790 ()
DYNJ48708C

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942118205

G PACK
MEDLINE INDUSTRIES, INC.
DYNJ48708B
In Commercial Distribution

  • 10889942118205 ()
DYNJ48708B

  • General surgical procedure kit, non-medicated, reusable

Knee Instruments - 07630971227705

"G" Adaptor
Medacta International SA
33.22.0141
In Commercial Distribution

  • 07630971227705 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

PDT, Inc. - 00813677021601

G 4-5
PDT, INC.
R294 G 4-5
In Commercial Distribution

  • 00813677021601 ()
R294

  • Dental restoration carver, amalgam, reusable

Leksell Stereotactic System - 07340201503263

FRAME G
Elekta Solutions AB
1040455
In Commercial Distribution

  • 07340201503263 ()
1040318

  • Neurological stereotactic surgery system

Vivid Nano Flow A 2 - D724D0102040

1 g
PEARSON DENTAL SUPPLIES, INC.
D010204
In Commercial Distribution

  • D724D0102040 ()


  • Light-cured dental restorative composite resin

Vivid Nano Flow bleach extra - D724D0102020

2 g
PEARSON DENTAL SUPPLIES, INC.
D010202
In Commercial Distribution

  • D724D0102020 ()


  • Light-cured dental restorative composite resin

Trinity Biotech - 05391516748742

EU – Lyme IgM Western Blot, Western Blot Test System for the Detection of IgM Antibodies to Borrelia afzelii “PKO” and Borrelia garinii, 40 Tests
MARDX DIAGNOSTICS, INC.
44-2020M
In Commercial Distribution

  • 05391516748742 ()
44-2020M

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
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