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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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Trophon US Refurbished
NANOSONICS LIMITED
N00010-US-RFB
In Commercial Distribution

  • 09350855000139 ()
  • 09350855000122 ()


  • Atomized-chemical device disinfector
Trophon EPR Nth America AHECC 8419.20.00 (NNA VARIANT)
NANOSONICS LIMITED
N00010-NNA
In Commercial Distribution

  • 09350855000115 ()
  • 09350855000016 ()


  • Atomized-chemical device disinfector
Trophon EPR USA Variant AHECC 8419.20.00 (GE VARIANT)
NANOSONICS LIMITED
N00010-US
In Commercial Distribution

  • 09350855000108 ()
  • 09350855000009 ()


  • Atomized-chemical device disinfector
No Description
TREK DIAGNOSTIC SYSTEMS LIMITED
GPID
In Commercial Distribution

  • M578GPID2 ()
  • M578GPID0 ()


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

  • M578GNID2 ()
  • M578GNID0 ()


  • Gram positive bacteria species culture isolate identification/antimicrobial susceptibility profile IVD, kit
Codebook Crystal Rgp Manual
BECTON, DICKINSON AND COMPANY
245041
Not in Commercial Distribution

  • 00382902450412 ()
245041

  • Microorganism identification analyser IVD, manual
Codebook Crystal Gram-Positive Manual
BECTON, DICKINSON AND COMPANY
245037
Not in Commercial Distribution

  • 00382902450375 ()
245037

  • Microorganism identification analyser IVD, manual
BD BBL™ CRYSTAL™ Identification Systems Enteric / Nonfermenter
BECTON, DICKINSON AND COMPANY
245002
Not in Commercial Distribution

  • 00382902450023 ()
245002

  • Microorganism identification analyser IVD, manual
PLATE DRY CLI GRAM+ ID AUTO A semi-quantitative test intended for the automated identification of Gram positive bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic.
REMEL, INC.
GPID
In Commercial Distribution

  • 00848838074363 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
PLATE DRY CLI GRAM+ ID AUTO -A semi-quantitative test intended for the automated identification of Gram negative bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic.
REMEL, INC.
GNID
In Commercial Distribution

  • 00848838074325 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
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