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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™ - 00816576020317

Amoxicillin/Clav. Acid 30μg (AmC30) 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
Z8021
In Commercial Distribution

  • 00816576020317 ()
  • 00816576021406 ()
Z8021

  • Amoxycillin/clavulanic acid susceptibility testing disc IVD

HardyDisk™ - 00816576020294

Amikacin 30μg (AN30) 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
Z8011
In Commercial Distribution

  • 00816576020294 ()
  • 00816576021390 ()
Z8011

  • Amikacin susceptibility testing disc IVD

FUSION Silane - D8370620200

Mixing bottle for FUSION Silane. 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
Mix Bottle - Empty
In Commercial Distribution

  • D8370620200 ()

  • Total Volume: 6 Milliliter
06-2020

  • Dental repair kit, ceramic

ELMED - 00842180123649

5MM DIA., 26 CM, HOOK SCISSORS, STRAIGHT SERRATED JAWS FOR MAX GRIP, DOUBLE-ACTION, INSULATED SHAFT & HANDLE W/ RF-POST, MODULAR 3-PIECE SCREW-APART
ELMED INCORPORATED
52626-03C
In Commercial Distribution

  • 00842180123649 ()
52626-03C

  • Laparoscope system, reusable

ELMED - 00842180122710

5MM DIA., 45 CM, HOOK SCISSORS, STRAIGHT SERRATED JAWS FOR MAX GRIP, DOUBLE-ACTION, INSULATED SHAFT & HANDLE W/ RF-POST, MODULAR 3-PIECE SCREW-APART
ELMED INCORPORATED
52615-03C
In Commercial Distribution

  • 00842180122710 ()
52615-03C

  • Laparoscope system, reusable

ELMED - 00842180111813

5MM DIA., 45CM REUSABLE MONOPOLAR BULLET SUCTION ELECTRODE WITH PROTECTOR SLEEVE FOR USE WITH CITRON/ACMI SURGI-FLEX DISPOSABLE SUCTION/IRRIGATION HANDLE
ELMED INCORPORATED
52645-446
In Commercial Distribution

  • 00842180111813 ()
52645-446

  • Laparoscope system, reusable

ELMED - 00842180111783

5MM DIA., 45CM REUSABLE MONOPOLAR "J" HOOK ELECTRODE WITH PROTECTOR SLEEVE FOR USE WITH CITRON/ACMI SURGI-FLEX DISPOSABLE SUCTION/IRRIGATION HANDLE
ELMED INCORPORATED
52645-443
In Commercial Distribution

  • 00842180111783 ()
52645-443

  • Laparoscope system, reusable

ELMED - 00842180111776

5MM DIA., 45CM REUSABLE MONOPOLAR "L" HOOK ELECTRODE WITH PROTECTOR SLEEVE FOR USE WITH CITRON/ACMI SURGI-FLEX DISPOSABLE SUCTION/IRRIGATION HANDLE
ELMED INCORPORATED
52645-442
In Commercial Distribution

  • 00842180111776 ()
52645-442

  • Laparoscope system, reusable

ELMED - 00842180111745

5MM DIA., 32CM REUSABLE MONOPOLAR BULLET SUCTION ELECTRODE WITH PROTECTOR SLEEVE FOR USE WITH CITRON/ACMI SURGI-FLEX DISPOSABLE SUCTION/IRRIGATION HANDLE
ELMED INCORPORATED
52632-446
In Commercial Distribution

  • 00842180111745 ()
52632-446

  • Laparoscope system, reusable

ELMED - 00842180111714

5MM DIA., 32CM REUSABLE MONOPOLAR "J" HOOK ELECTRODE WITH PROTECTOR SLEEVE FOR USE WITH CITRON/ACMI SURGI-FLEX DISPOSABLE SUCTION/IRRIGATION HANDLE
ELMED INCORPORATED
52632-443
In Commercial Distribution

  • 00842180111714 ()
52632-443

  • Laparoscope system, reusable
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