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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 5mm 1x Nozzle (Black)
ENERGIST LIMITED
NeoGen 5mm 1x Nozzle (Black)
In Commercial Distribution

  • 15060440520195 ()
  • 05060440520198 ()
830-006

  • Nitrogen plasma skin surface treatment system
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
Hybernite RT 114
Plastiflex Group NV
RT 114
In Commercial Distribution

  • 15404013003737 ()
  • 05404013003730 ()
HFN19022BT1STWGL

  • Ventilator breathing circuit, single-use
Hybernite RT 114 Convenience kit
Plastiflex Group NV
RT 114 Convenience kit
In Commercial Distribution

  • 05404013003693 ()
  • 15404013003690 ()
HFN19022BT1STWGO

  • Ventilator breathing circuit, single-use
No Description
Plastiflex Group NV
Classic RT 19 x 1830 White
In Commercial Distribution

  • 15404013002242 ()
  • 05404013002245 ()
  • 25404013002249 ()


  • Ventilator breathing circuit, single-use
No Description
Plastiflex Group NV
Classic RT 19 x 1830 Blue
In Commercial Distribution

  • 15404013002204 ()
  • 05404013002207 ()
  • 25404013002201 ()


  • Ventilator breathing circuit, single-use
No Description
Plastiflex Group NV
Classic RT 19 x 1500 White
In Commercial Distribution

  • 15404013002198 ()
  • 05404013002191 ()
  • 25404013002195 ()


  • Ventilator breathing circuit, single-use
No Description
Plastiflex Group NV
Classic RT 19 x 1500 Blue
In Commercial Distribution

  • 15404013002181 ()
  • 05404013002184 ()
  • 25404013002188 ()


  • Ventilator breathing circuit, single-use
No Description
Plastiflex Group NV
Classic RT 19 x 1200 White
In Commercial Distribution

  • 15404013002174 ()
  • 05404013002177 ()
  • 25404013002171 ()


  • Ventilator breathing circuit, single-use
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