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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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HardyDisk™ - 00816576020393

Carbenicillin 100μg (CB100) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8115
In Commercial Distribution

  • 00816576020393 ()
  • 00816576021420 ()
Z8115

  • Carbenicillin susceptibility testing disc IVD

HardyDisk™ - 00816576020379

Azithromycin 15μg (AZM15) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8051
In Commercial Distribution

  • 00816576020379 ()
  • 00816576021413 ()
Z8051

  • Azithromycin susceptibility testing disc IVD

HardyDisk™ - 00816576020348

Ampicillin 10μg (AM10) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8035
In Commercial Distribution

  • 00816576020348 ()
  • 00816576021635 ()
Z8035

  • Ampicillin susceptibility testing disc IVD

HardyDisk™ - 00816576020331

Ampicillin 10μg (AM10) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8031
In Commercial Distribution

  • 00816576020331 ()
  • 00816576021635 ()
Z8031

  • Ampicillin susceptibility testing disc IVD

HardyDisk™ - 00816576020300

Amikacin 30μg (AN30) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (KirbyBauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8015
In Commercial Distribution

  • 00816576020300 ()
  • 00816576021390 ()
Z8015

  • Amikacin susceptibility testing disc IVD

URiSCAN Optima - 08806125619033

The URiSCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer and URiSCAN urine test strips. The intended use of the URiSCAN Optima Urine analyzer is to read the color change on the test pads found on the URiSCAN urine test strips and to display and print the results. These measurements are useful in the evaluation of renal, urinary and metabolic disorders.
YD Diagnostics CORP.
Optima
In Commercial Distribution

  • 08806125619033 ()


  • Urine analyser IVD, laboratory, semi-automated

RetroMTA(RetroMTA-OrthoMTAII) - 08800027200054

RetroMTA is an ideal material for vital pulp therapy and root repair. Setting is 150 seconds (W/P=1/0.28). There is no heavy metal contents in it and no discoloration after application. RetroMTA has a wide variety of clinical indications such as for pulp capping or pulpotomy for deciduous and young teeth, apexification and base cement for prevention of discoloration or for tooth whitening procedure.
BioMTA
RM02
In Commercial Distribution

  • 08800027200054 ()


  • Endodontic filling/sealing material

RetroMTA(RetroMTA-OrthoMTAII) - 08800027200047

RetroMTA is an ideal material for vital pulp therapy and root repair. Setting is 150 seconds (W/P=1/0.28). There is no heavy metal contents in it and no discoloration after application. RetroMTA has a wide variety of clinical indications such as for pulp capping or pulpotomy for deciduous and young teeth, apexification and base cement for prevention of discoloration or for tooth whitening procedure.
BioMTA
RM08
In Commercial Distribution

  • 08800027200047 ()


  • Endodontic filling/sealing material

FUSION Silane - D8370620110

A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic restorations, and recommended for best adhesion to veneers, crowns and other ceramic restorations. Also use it for easy chair-side repairs to: porcelain-gold restorations, porcelain jackets, porcelain denture teeth, popped-out porcelain veneers or facings. Eliminates costly laboratory remakes. This non-toxic, non-irritating formula can be used in or out of the mouth.
Taub Products
B - 6 oz
In Commercial Distribution

  • D8370620110 ()

  • Total Volume: 6 Fluid Ounce
06-2011

  • Dental repair kit, ceramic

FUSION Silane - D8370620100

A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic restorations, and recommended for best adhesion to veneers, crowns and other ceramic restorations. Also use it for easy chair-side repairs to: porcelain-gold restorations, porcelain jackets, porcelain denture teeth, popped-out porcelain veneers or facings. Eliminates costly laboratory remakes. This non-toxic, non-irritating formula can be used in or out of the mouth.
Taub Products
B
In Commercial Distribution

  • D8370620100 ()

  • Total Volume: 6 Milliliter
06-2010

  • Dental repair kit, ceramic
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