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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STANDARD SHIELD - 24 x 48 - 0.50mm Lead Equivalence -LEAD FREE PROTECTIVE MEDIA - Star Base
Techno-Aide, Inc.
LPSG-S2448
In Commercial Distribution

  • G242LPSGS244890 ()
  • G242LPSGS24489 ()
LPSG-S2448

  • Radiation shielding panel, portable/mobile
STANDARD SHIELD - 24 x 36 - 0.50mm Lead Equivalence -LEAD FREE PROTECTIVE MEDIA - Star Base
Techno-Aide, Inc.
LPSG-S2436
In Commercial Distribution

  • G242LPSGS243690 ()
  • G242LPSGS24369 ()
LPSG-S2436

  • Radiation shielding panel, portable/mobile
STANDARD SHIELD - 24 x 24 - 0.50mm Lead Equivalence -LEAD FREE PROTECTIVE MEDIA - Star Base
Techno-Aide, Inc.
LPSG-S2424
In Commercial Distribution

  • G242LPSGS242490 ()
  • G242LPSGS24249 ()
LPSG-S2424

  • Radiation shielding panel, portable/mobile
Radiation Protective Portable Shield
Stevens-Moon Sales Professionals LLC
PS
In Commercial Distribution

  • G309PS0 ()
PS

  • Radiation shielding panel, portable/mobile
DAU+ V2 F OT
UTAK LABORATORIES, INC.
URINE PAIN PANEL
In Commercial Distribution

  • B800DAUV2FOT5 ()
  • B800DAUV2FOT0 ()

  • Total Volume: 1 Milliliter
URINE PAIN PANEL

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Aktina Corp.
51-225
In Commercial Distribution

  • B365512250 ()


  • Indexed-immobilization patient positioning system
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
Pregnancy Panel Insert - 0.5mm Regular Lead
Shielding International Inc.
PPIRL
In Commercial Distribution

  • G031PPIRL0 ()


  • Radiation shielding apron
Dental Control Unit
Proma, Inc.
Control Unit
In Commercial Distribution

  • D142DCU01 ()


  • Dental delivery system instrument unit, pneumatic
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