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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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Reusable Tapered Cleaning Brush. HIBC/UPN: M45381150
Primed Instruments Inc
8115
In Commercial Distribution

  • 00666416110025 ()

  • Minimum Channel Size: 2.0mm
  • Brush Diameter: 3.0-5.0mm
  • Working Length: 115cm
8115

  • Endoscope cleaning brush, reusable
Reusable Tapered Cleaning Brush. HIBC/UPN: M45381070
Primed Instruments Inc
8107
Not in Commercial Distribution

  • 00666416110018 ()

  • Minimum Channel Size: 2.0mm
  • Brush Diameter: 3.0-5.0mm
  • Working Length: 70cm
8107

  • Endoscope cleaning brush, reusable
For the Kinetic Quantitative Determination of ALT/GPT in Serum and Plasma.
STANBIO LABORATORY, L.P.
S2930-600
In Commercial Distribution

  • 00657498001677 ()
S2930-600

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
Creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine.
STANBIO LABORATORY, L.P.
S2910-600
In Commercial Distribution

  • 00657498001653 ()
S2910-600

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
For the Kinetic Quantitative Determination of Urea Nitrogen (BUN) in Serum and Plasma.
STANBIO LABORATORY, L.P.
S2020-600
In Commercial Distribution

  • 00657498001622 ()
S2020-600

  • Urea IVD, kit, enzyme spectrophotometry
For the Quantitative Determination of Creatinine in Serum and Urine.
STANBIO LABORATORY, L.P.
S0430-600
In Commercial Distribution

  • 00657498001554 ()
S0430-600

  • Creatinine IVD, kit, enzyme spectrophotometry
For the Quantitative Colorimetric Determination of Direct Bilirubin in Serum or Plasma.
STANBIO LABORATORY, L.P.
S0235-600
In Commercial Distribution

  • 00657498001493 ()
S0235-600

  • Conjugated (direct) bilirubin IVD, kit, enzyme spectrophotometry
For the Quantitative Colorimetric Determination of Total Bilirubin in Serum and Plasma.
STANBIO LABORATORY, L.P.
S0230-600
In Commercial Distribution

  • 00657498001486 ()
S0230-600

  • Total bilirubin IVD, kit, enzyme spectrophotometry
For the Quantitative Colorimetric Determination of Hemoglobin in Whole Blood.
STANBIO LABORATORY, L.P.
0325-006
Not in Commercial Distribution

  • 00657498001158 ()
0325-006

  • Cyanomethemoglobin kit
For the Quantitative Colorimetric Determination of Urea Nitrogen in Serum, Plasma or Urine.
STANBIO LABORATORY, L.P.
0580-250
In Commercial Distribution

  • 00657498001097 ()
0580-250

  • Urea IVD, kit, enzyme spectrophotometry
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