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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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BAND SIM SRB 800SC24 SEMI-RIGID 24MM
MEDTRONIC, INC.
800SC24
Not in Commercial Distribution

  • 00643169300880 ()

  • Lumen/Inner Diameter: 24.0 Millimeter


  • Mitral annuloplasty ring
The Capture Screw System is comprised of Digital screws used for bone fixation of the hand and foot, following trauma or osteotomy. All screws are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The Digital Screw is a cannulated, threaded bone screw which is offered in a 2.0mm diameter with lengths of 24 – 50mm. The system includes instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
CAPDIGITIMP
Not in Commercial Distribution

  • M268CAPDIGITIMP1 ()
  • 10381780064503 ()
CAPDIGITIMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Integra Ti6 Internal Fixation System is comprised of Low Profile screws used for bone fixation of the hand and foot following trauma or osteotomy. The low profile screw is a cannulated, threaded bone screw which is offered in 2.0, 2.5, 3.0 and 4.0 diameters with lengths of 2.0, 2.5, 3.0, and 4.0. The system includes titanium and stainless steel instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
TI6LOPROIMP
Not in Commercial Distribution

  • M268TI6LOPROIMP1 ()
  • 10381780074328 ()
TI6LOPROIMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Ceftolozane 30μg Tazobactam 10μg (C/T40) 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
Z9345
In Commercial Distribution

  • 00816576022045 ()
  • 00816576022021 ()
Z9345

  • Multiple antibacterial susceptibility profile kit IVD
Ceftolozane 30μg Tazobactam 10μg (C/T40) 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
Z9341
In Commercial Distribution

  • 00816576022038 ()
  • 00816576022021 ()
Z9341

  • Multiple antibacterial susceptibility profile kit IVD
Ceftazidime 30μg Avibactam 20μg (CZA50) 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
Z9355
In Commercial Distribution

  • 00816576022014 ()
  • 00816576021994 ()
Z9355

  • Multiple antibacterial susceptibility profile kit IVD
Ceftazidime 30μg Avibactam 20μg (CZA50) 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
Z9351
In Commercial Distribution

  • 00816576022007 ()
  • 00816576021994 ()
Z9351

  • Multiple antibacterial susceptibility profile kit IVD
Sulpha/Trimeth 25μg (SXT25) 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
Z9015
In Commercial Distribution

  • 00816576020973 ()
  • 00816576021758 ()
Z9015

  • Sulphamethoxazole/trimethoprim susceptibility testing disc IVD
Sulpha/Trimeth 25μg (SXT25) 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
Z9011
In Commercial Distribution

  • 00816576020966 ()
  • 00816576021758 ()
Z9011

  • Sulphamethoxazole/trimethoprim susceptibility testing disc IVD
Piperacillin/Tazobactam 110μg (TZP110) 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
Z8915
In Commercial Distribution

  • 00816576020935 ()
  • 00816576021734 ()
Z8915

  • Piperacillin/tazobactam susceptibility testing disc IVD
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