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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
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
The HDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the diagnosis and treatment of patients at risk for developing coronary heart disease.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 2 x 70mL, R2 x 1 x 50mL
In Commercial Distribution

  • 00812137012067 ()
  • 00812137012319 ()
501-419

  • High density lipoprotein (HDL) cholesterol IVD, reagent
For the quantitative determination of magnesium in serum. For in vitro diagnostic use only. Magnesium in the body is found primarily in bone with some in soft tissue, blood cells, and serum. Decreased levels have been observed in cases of diabetes, alcoholism, diuretics, hyperthyroidism, hypothyroidism, malabsorption, hyperalimenation, myocardial infarction, congestive heart failure and liver cirrhosis. Increased serum magnesium levels have been found in renal failure, diabetic acidosis, Addison’s disease, and vitamin D intoxication.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 2 x 120mL, R2 x 2 x 120mL
In Commercial Distribution

  • 00812137012012 ()
  • 00812137012364 ()
501-414

  • Magnesium (Mg2+) IVD, reagent
No Description
CRAWFORD HEALTHCARE LIMITED
20 x 1 x 0.1in
In Commercial Distribution

  • 05060077234123 ()
  • 05060077230644 ()
  • 05060077230637 ()
KPRO60

  • Pressure-management bandage, silicone
No Description
CRAWFORD HEALTHCARE LIMITED
12 x 2 x 0.1in
In Commercial Distribution

  • 05060077234116 ()
  • 05060077230620 ()
  • 05060077230583 ()
KPRO50

  • Pressure-management bandage, silicone
No Description
CRAWFORD HEALTHCARE LIMITED
4 x 4 x 0.5in
In Commercial Distribution

  • 05060077230392 ()
  • 05060077230446 ()
  • 05060077234109 ()

  • Depth: 0.5 Inch
  • Length: 4 Inch
  • Height: 4 Inch
KPRO20

  • Pressure-management bandage, silicone
Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). To be used for management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. Minimizes tissue attachment to the device in case of direct contact with the tissues. Also indicated for reinforcement of soft tissues repaired by suture or suture anchors, during tendon repair surgery. Reinforces soft tissue and provides a remodelable scaffold that is replaced by the patient’s own soft tissue. The device is indicated for open and laparoscopic/endoscopic procedures.
MAST BIOSURGERY USA INC.
50 x 70 x 0.05mm
Not in Commercial Distribution

  • 18964050475012 ()
  • 08964050475015 ()

  • Thickness: 0.05 Millimeter
  • Length: 70 Millimeter
  • Width: 50 Millimeter
47501-01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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