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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 3x Nozzle (Black)
ENERGIST LIMITED
NeoGen 5mm 3x Nozzle (Black)
In Commercial Distribution

  • 15060440520232 ()
  • 05060440520235 ()
830-057

  • Nitrogen plasma skin surface treatment system
NeoGen 25mm 1x Nozzle (Grey)
ENERGIST LIMITED
NeoGen 25mm 1x Nozzle (Grey)
In Commercial Distribution

  • 15060440520225 ()
  • 05060440520228 ()
830-023

  • Nitrogen plasma skin surface treatment system
NeoGen 5mm 1x Nozzle (Grey)
ENERGIST LIMITED
NeoGen 5mm 1x Nozzle (Grey)
In Commercial Distribution

  • 15060440520218 ()
  • 05060440520211 ()
830-033

  • Nitrogen plasma skin surface treatment system
NeoGen 25mm 1x Nozzle (Black)
ENERGIST LIMITED
NeoGen 25mm 1x Nozzle (Black)
In Commercial Distribution

  • 15060440520201 ()
  • 05060440520204 ()
830-024

  • Nitrogen plasma skin surface treatment system
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
Handpiece Complete (Grey)
ENERGIST LIMITED
Handpiece Gry
In Commercial Distribution

  • 05060440520129 ()
830-031

  • 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
ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify anatomy in live ultrasound images. The Anatomy PNB receives scan images in real-time from a compatible general-purpose ultrasound machine. It then processes the images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The original view from the ultrasound machine is not affected and is always available both on the ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V2.0
Not in Commercial Distribution

  • 05060878810052 ()


  • Ultrasound imaging system application software
ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify anatomy in live ultrasound images. The Anatomy PNB receives scan images in real-time from a compatible general-purpose ultrasound machine. It then processes the images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The original view from the ultrasound machine is not affected and is always available both on the ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V1.1
Not in Commercial Distribution

  • 05060878810021 ()


  • Ultrasound imaging system application software
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