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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SPINOMED ANTERIOR PANEL
MEDI MANUFACTURING, INC.
SL11321
In Commercial Distribution

  • 00636257038116 ()


  • Cervicothoracic spine orthosis
No Description
TREK DIAGNOSTIC SYSTEMS LIMITED
GNID
In Commercial Distribution

  • M578GNID2 ()
  • M578GNID0 ()


  • Gram positive bacteria species culture isolate identification/antimicrobial susceptibility profile IVD, kit
No Description
TREK DIAGNOSTIC SYSTEMS LIMITED
GPID
In Commercial Distribution

  • M578GPID2 ()
  • M578GPID0 ()


  • Gram positive bacteria species culture isolate identification/antimicrobial susceptibility profile IVD, kit
SP SAPH3 SS LIGHT PANEL
TELEFLEX INCORPORATED
IPN010269
In Commercial Distribution

  • 34026704411048 ()
  • 24026704411041 ()
  • 44026704411045 ()

  • Width: 2 Inch
  • Depth: 0.45 Inch
  • Length: 4.049 Inch
89-2718K

  • Surgical instrument fibreoptic light
SP SAPH3 M LIGHT PANEL
TELEFLEX INCORPORATED
IPN010268
In Commercial Distribution

  • 34026704411031 ()
  • 24026704411034 ()
  • 44026704411038 ()

  • Width: 2 Inch
  • Length: 5.328 Inch
  • Depth: 0.45 Inch
89-2717K

  • Surgical instrument fibreoptic light
SAPH III L LIGHT PANEL
TELEFLEX INCORPORATED
IPN010267
In Commercial Distribution

  • 44026704411021 ()
  • 34026704411024 ()
  • 24026704411027 ()

  • Depth: 0.45 Inch
  • Width: 2 Inch
  • Length: 6.927 Inch
89-2716K

  • Surgical instrument fibreoptic light
The Piccolo® Lipid Panel reagent disc, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® Chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), and triglycerides (TRIG) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From these determinations low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer. Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders. This test is waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the test is considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0025
In Commercial Distribution

  • EABA40000251 ()
  • EABA40000250 ()
400-0025

  • Glucose/ketone/lipid profile IVD, reagent
The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, potassium, sodium, and total carbon dioxide in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0022
In Commercial Distribution

  • EABA40000221 ()
  • EABA40000220 ()
400-0022

  • Chloride (Cl-) IVD, reagent
  • Sodium (Na+) IVD, control
  • Bicarbonate (HCO3-) IVD, reagent
  • Potassium (K+) IVD, reagent
No Description
BURKHART DENTAL SUPPLY CO., THE
72720856
In Commercial Distribution

  • 00815878023279 ()


  • Medical equipment drape, single-use, non-sterile
No Description
BURKHART DENTAL SUPPLY CO., THE
72720857
In Commercial Distribution

  • 00815878023262 ()


  • Medical equipment drape, single-use, non-sterile
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