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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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Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-141C
CODONICS INC.
500i PCS -141C
In Commercial Distribution

  • 00814905020243 ()


  • Parenteral-nutrition management software
Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-140C
CODONICS INC.
500i PCS -140C
In Commercial Distribution

  • 00814905020236 ()


  • Parenteral-nutrition management software
Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items
CODONICS INC.
500i PCS
In Commercial Distribution

  • 00814905020229 ()


  • Parenteral-nutrition management software
No Description
HELENA LABORATORIES CORPORATION
1679000
In Commercial Distribution

  • M52516790000 ()


  • Densitometry analyser IVD
Lightweight, portable, state of the art three-component force platform, measuring the vertical ground reaction force and its point of application (CoP). Its large surface allows for any stance. It is sensitive enough to pick up the changes in the vertical ground reaction force produced by the beating of the heart and the blood ejection in the aorta (including the modulation produced by the breathing cycle), while the subject is standing on the top surface. It satisfies the International Society for Posture and Gait Research (ISPGR) recommendations for clinical posturography. It is intended to be used as aid in fall risk screening; posturography (static and dynamic); weight, balance, and postural control assessment; mechanography; physical performance investigations; and objective tracking of treatment efficacy and disease progress. Covered by one or more US patents.
VESTIBULAR TECHNOLOGIES, LLC
Professional
In Commercial Distribution

  • B702P31C0 ()
P31C

  • Biomechanical function analysis/interactive rehabilitation system
  • Posturography system
  • Posturography system platform
  • Stand-on floor scale, electronic
1 Soan handpiece 1 wireless pedal 1 battery charger 1 power supply, 5 containers 1 user manual 2 boxes of dental needles C3022 (primary DI Number: 03760349800507) 1 box of dental needles C3025 (primary DI Number: 03760349800521)
DENTALHITEC
SOAN1
In Commercial Distribution

  • 03760349809951 ()
  • 03760349805335 ()
SOAN1

  • Dental computer assisted anaesthesia injection unit
  • Dental syringe needle, single-use
Multi-exercise respiratory therapy device with OmniFlow software and sensor, and Synchrony software, electrodes, and sensing devices
ACCELERATED CARE PLUS CORP
100MTS
In Commercial Distribution

  • 00858703006320 ()


  • Bioelectrical signal analysis software
  • Biomechanical function analysis/interactive rehabilitation system
  • Monitoring spirometer, mechanical
Software and sensor designed to provide visual feedback to respiratory patients.
ACCELERATED CARE PLUS CORP
100FLO
In Commercial Distribution

  • 00858703006276 ()


  • Bioelectrical signal analysis software
  • Biomechanical function analysis/interactive rehabilitation system
  • Monitoring spirometer, mechanical
Flood Phantom, Rectangular, Fillable
BIODEX MEDICAL SYSTEMS, INC.
243-054
In Commercial Distribution

  • 00718175000540 ()
243-054

  • Nuclear medicine phantom, flood source
No Description
Sanders Medical Products, Inc.
PET-LINE
In Commercial Distribution

  • 00850055164017 ()


  • Nuclear medicine phantom, line source
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