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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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CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600436-001
In Commercial Distribution

  • J00716004360011 ()
1600436-001

  • Dental power tool system handpiece, remotely-driven
No Description
Baylis Médicale Cie Inc
PSZ-300-203
Not in Commercial Distribution

  • 00685447001997 ()


  • Fascial tissue dilator, reusable
Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed
Immunostics Company, Inc
IDU-2PG
In Commercial Distribution

  • 20722355002181 ()
  • 10722355002245 ()
  • 80722355002244 ()


  • Urine glucose IVD, kit, rapid colorimetric, clinical
  • Urine protein IVD, kit, rapid colorimetric, clinical
BUDDY 2 SYSTEM,GERMANY
BELMONT INSTRUMENT CORPORATION
905-00037-G
Not in Commercial Distribution

  • 00896128002855 ()


  • Conduction blood/fluid warmer
BUDDY 2 SYSTEM, UK
BELMONT INSTRUMENT CORPORATION
905-00037-UK
Not in Commercial Distribution

  • 00896128002848 ()


  • Conduction blood/fluid warmer
BUDDY 2 SYSTEM, ENGLISH
BELMONT INSTRUMENT CORPORATION
905-00037-E
Not in Commercial Distribution

  • 00896128002831 ()


  • Conduction blood/fluid warmer
CD WITH 9.02 software version
BIOMERIEUX , INC.
9.02.0
In Commercial Distribution

  • 03573026609399 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated
VITEK®2 software 9.01.0, advanced software to run your VITEK®2 system
BIOMERIEUX , INC.
9.01.0
Not in Commercial Distribution

  • 03573026555504 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
VITEK®2 XL is an automated system that performs large volumes of bacterial ID & AST testings
BIOMERIEUX , INC.
27227R
In Commercial Distribution

  • 03573026206789 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
VITEK®2 60 is an automated system that performs bacterial ID and AST. A total of 60 ID and/or AST cards can be processed simultaneously per run.
BIOMERIEUX , INC.
27225R
In Commercial Distribution

  • 03573026206765 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
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