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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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Neogen Handpiece Complete (Black)
ENERGIST LIMITED
Handpiece Blk
In Commercial Distribution

  • 05060440520105 ()
830-009

  • Nitrogen plasma skin surface treatment system
A mobile assembly of devices intended to treat a variety of skin conditions (e.g., acne scars, actinic keratosis, wrinkles, superficial skin lesions, warts) through controlled heating of the skin surface via application of nitrogen plasma. It consists of a mains electricity (AC-powered) generator/control unit and a hand-held applicator; it may include a N2 cylinder(s) and additional hardware (e.g., foot-switch). Typically radio-frequency energy is used to convert N2 into N2 plasma which exits the handpiece as a pulsed beam. This device is intended to be used by a professional in a clinical setting.
ENERGIST LIMITED
PSR
In Commercial Distribution

  • 05060440520099 ()
830-008

  • Nitrogen plasma skin surface treatment system
No Description
EMIT CORPORATION
FA100004
In Commercial Distribution

  • 00850003277042 ()
  • 00850003277073 ()
  • 00850003277066 ()
  • 00850003277059 ()
  • 00850003277097 ()
  • 00850003277080 ()


  • Conduction blood/fluid warmer
No Description
EMIT CORPORATION
FA100001
In Commercial Distribution

  • 00850003277035 ()
  • 00850003277004 ()
  • 00850003277011 ()
  • 00850003277028 ()
  • 00850003277110 ()
  • 00850003277103 ()


  • Conduction blood/fluid warmer
Kelvi Hip Pro Smart Wrap, Right
HYPOTHERMIA DEVICES, INC.
KLV20009
In Commercial Distribution

  • 00850001185110 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Hip Pro Smart Wrap, Left
HYPOTHERMIA DEVICES, INC.
KLV20008
In Commercial Distribution

  • 00850001185103 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Hand Station
HYPOTHERMIA DEVICES, INC.
KLV20005
In Commercial Distribution

  • 00850001185073 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Ankle Pro Smart Wrap
HYPOTHERMIA DEVICES, INC.
KLV20004
In Commercial Distribution

  • 00850001185059 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Knee Pro Smart Wrap
HYPOTHERMIA DEVICES, INC.
KLV20003
In Commercial Distribution

  • 00850001185042 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Back Pro Smart Wrap
HYPOTHERMIA DEVICES, INC.
KLV20002
In Commercial Distribution

  • 00850001185035 ()


  • Circulating-fluid localized thermal therapy system
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