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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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3100B Disposable Items Kit / F&P 730
VYAIRE MEDICAL, INC.
775854
In Commercial Distribution

  • 10190752158818 ()
775854

  • Breathing circuit condensate trap, single-use
  • Respiratory gas heating wire, adult
  • Carpal lunate prosthesis
  • Microbial medical gas filter, single-use
3100B Disposable Items Kit / HRCI
VYAIRE MEDICAL, INC.
775853
In Commercial Distribution

  • 10190752158801 ()
775853

  • Respiratory gas heating wire, adult
  • Carpal lunate prosthesis
  • Microbial medical gas filter, single-use
  • Breathing circuit condensate trap, single-use
GuttaSil, a product in the form of a paste which combines gutta-percha with a sealer. The gutta-percha powder is mixed in a matrix of polyvinylsiloxane. It is convenient since sealing and obturation are simultaneously possible without heating and the root canal can be filled in a quick manner. This device contains a syringe, auto-mix& Endo tips, spatula, and mixing pads.
Meta Biomed Co., Ltd.
9411
Not in Commercial Distribution

  • 08806387894117 ()


  • Hygroscopic dental cement
GuttaSil, a product in the form of a paste which combines gutta-percha with a sealer. The gutta-percha powder is mixed in a matrix of polyvinylsiloxane. It is convenient since sealing and obturation are simultaneously possible without heating and the root canal can be filled in a quick manner. This device contains a syringe, auto-mix& Endo tips, spatula, and mixing pads.
Meta Biomed Co., Ltd.
9387
Not in Commercial Distribution

  • 08806387893875 ()


  • Hygroscopic dental cement
SATELECĀ® autoclavable LED light handpiece with the Air Active function. Extremely powerful LED light (65 000 LUX) for an excellent visibility, even in posterior areas. Air Active, exclusive endo function : elimination of dentinal debris and dry work without heating.
SATELEC
PMAX XS 115V tips
In Commercial Distribution

  • 03609820585130 ()
F58513

  • Ultrasonic dental scaling/debridement system
SATELECĀ® autoclavable LED light handpiece with the Air Active function. Extremely powerful LED light (65 000 LUX) for an excellent visibility, even in posterior areas. Air Active, exclusive endo function : elimination of dentinal debris and dry work without heating.
SATELEC
PMAX XS 115V
In Commercial Distribution

  • 03609820585109 ()
F58510

  • Ultrasonic dental scaling/debridement system
CM4, 5CM, LASER MODULE, 2X2 MS FOAM, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
COMPASS HEALTH BRANDS CORP.
410-012
Not in Commercial Distribution

  • 00852515007513 ()


  • Ultrasound coupling pad holder
  • Transcutaneous electrical stimulation electrode, single-use
  • Physical therapy ultrasound system applicator, hand-held
  • Physical therapy ultrasound/neuromuscular stimulation system
CM4, THERAPY HAMMER, LASER MODULE, 2X2 MS FOAM, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
COMPASS HEALTH BRANDS CORP.
410-012
Not in Commercial Distribution

  • 00852515007490 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Physical therapy ultrasound system applicator, hand-held
  • Physical therapy ultrasound/neuromuscular stimulation system
  • Ultrasound coupling pad holder
CM4, THERAPY HAMMER,LASER MODULE, AUTOSOUND, 2X2 MS FOAM, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
COMPASS HEALTH BRANDS CORP.
410-012
Not in Commercial Distribution

  • 00852515007476 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Physical therapy ultrasound system applicator, hand-held
  • Physical therapy ultrasound/neuromuscular stimulation system
  • Ultrasound coupling pad holder
CM4 220, 5CM, LASER MODULE, 2X2 MS FOAM, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
COMPASS HEALTH BRANDS CORP.
410-012-220
Not in Commercial Distribution

  • 00852515007391 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Physical therapy ultrasound system applicator, hand-held
  • Physical therapy ultrasound/neuromuscular stimulation system
  • Ultrasound coupling pad holder
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