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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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No Description
XENCO MEDICAL LLC
XM-216-1308
In Commercial Distribution

  • B064XM21613081 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1307
In Commercial Distribution

  • B064XM21613071 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1306
In Commercial Distribution

  • B064XM21613061 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1305
In Commercial Distribution

  • B064XM21613051 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1304
In Commercial Distribution

  • B064XM21613041 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
ALIMED, INC.
9-503
In Commercial Distribution

  • 00733657244304 ()
2970017446

  • Traction weight
Saw blade 29 x 12 x 0.4mm for MOS
Nouvag AG
5119NOU
In Commercial Distribution

  • ENOU5119NOU9 ()
  • ENOU5119NOU0 ()


  • Surgical saw blade, oscillating, reusable
Saw blade 17 x 10 x 0.4mm for MOS
Nouvag AG
5118NOU
In Commercial Distribution

  • ENOU5118NOU9 ()
  • ENOU5118NOU0 ()


  • Surgical saw blade, oscillating, reusable
Saw blade 17 x 6 x 0.4mm for MOS
Nouvag AG
5117NOU
In Commercial Distribution

  • ENOU5117NOU9 ()
  • ENOU5117NOU0 ()


  • Surgical saw blade, oscillating, reusable
Saw blade 12 x 6 x 0.4mm for MOS
Nouvag AG
5116NOU
In Commercial Distribution

  • ENOU5116NOU9 ()
  • ENOU5116NOU0 ()


  • Surgical saw blade, oscillating, reusable
Saw blade 12 x 4 x 0.4mm for MOS
Nouvag AG
5115NOU
In Commercial Distribution

  • ENOU5115NOU9 ()
  • ENOU5115NOU0 ()


  • Surgical saw blade, oscillating, reusable
Saw blade 12 x 6 x 0.4mm for MOS
Nouvag AG
5114NOU
In Commercial Distribution

  • ENOU5114NOU9 ()
  • ENOU5114NOU0 ()


  • Surgical saw blade, oscillating, reusable
Sterile Polyester Tipped Applicators
Puritan Medical Products
25-800 2PDBG
In Commercial Distribution

  • 50609576381299 ()
  • 00609576381294 ()
25-800 2PDBG

  • General-purpose absorbent tip applicator/swab, single-use
No Description
Feeltech Co.,Ltd.
1FT x FDN38
In Commercial Distribution

  • 18800145513828 ()
  • 08800145513821 ()
  • 28800145513825 ()


  • General-purpose syringe/needle
No Description
Feeltech Co.,Ltd.
1FT x FDN37
In Commercial Distribution

  • 18800145513811 ()
  • 08800145513814 ()
  • 28800145513818 ()


  • General-purpose syringe/needle
No Description
Feeltech Co.,Ltd.
1FT x FDN24
In Commercial Distribution

  • 18800145513804 ()
  • 08800145513807 ()
  • 28800145513801 ()


  • General-purpose syringe/needle
No Description
Feeltech Co.,Ltd.
1FT x FDN3
In Commercial Distribution

  • 18800145513798 ()
  • 08800145513791 ()
  • 28800145513795 ()


  • General-purpose syringe/needle
This product is for the purpose of monitoring accuracy and precision in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. Throughout the circulatory life of the red cell, Hemoglobin A1c is formed continuously by the adduction of glucose to the N-terminal of the hemoglobin beta chain. This process, which is non-enzymatic, reflects the average exposure of hemoglobin to glucose over an extended period.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
L1 x 2 x 0.5mL, L2 x 2 x 0.5mL
In Commercial Distribution

  • 00812137012166 ()
  • 00812137012449 ()
502-156

  • Glycated haemoglobin (HbA1c) IVD, control
These CRP Controls Set are intended for use in CRP test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.2 For in vitro diagnostic use only. C-reactive protein (CRP) is described in the literature as an acute phase protein that is involved in the activation of complement, acceleration of phagocytosis, and detoxification of substances released from damaged tissue. CRP is one of the most sensitive indicators of inflammation.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
L1 x 3 x 3mL, L2 x 3 x 3mL
In Commercial Distribution

  • 00812137012159 ()
  • 00812137012425 ()
502-155

  • C-reactive protein (CRP) IVD, control
The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 2 x 70mL, R2 x 1 x 50mL
In Commercial Distribution

  • 00812137012074 ()
  • 00812137012340 ()
501-420

  • Dense low density lipoprotein (DLDL) cholesterol IVD, kit, mass spectrometry
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