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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 - 05060440520099

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

UltraSPECT - 00850040177121

WBR Imaging X + X3 + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177121 ()


  • SPECT system application software

UltraSPECT - 00850040177114

WBR Imaging X3 + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177114 ()


  • SPECT system application software

UltraSPECT - 00850040177107

WBR Imaging X + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177107 ()


  • SPECT system application software

UltraSPECT - 00850040177091

WBR Imaging X + X3 + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177091 ()


  • SPECT system application software

UltraSPECT - 00850040177084

WBR Imaging X3 + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177084 ()


  • SPECT system application software

UltraSPECT - 00850040177077

WBR Imaging X + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177077 ()


  • SPECT system application software

UltraSPECT - 00850040177060

WBR Imaging X + X3 + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177060 ()


  • SPECT system application software

UltraSPECT - 00850040177053

WBR Imaging X3 + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177053 ()


  • SPECT system application software

UltraSPECT - 00850040177046

WBR Imaging X + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177046 ()


  • SPECT system application software
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