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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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Panosol 6 - 00850054882097

UVB-640
DAAVLIN DISTRIBUTING CO., THE
Panosol 6
In Commercial Distribution

  • 00850054882097 ()


  • Ultraviolet phototherapy unit, professional

Panosol 6 - 00850054882080

UVA-660
DAAVLIN DISTRIBUTING CO., THE
Panosol 6
In Commercial Distribution

  • 00850054882080 ()


  • Ultraviolet phototherapy unit, professional

Panosol 6 - 00850054882073

UVA-640
DAAVLIN DISTRIBUTING CO., THE
Panosol 6
In Commercial Distribution

  • 00850054882073 ()


  • Ultraviolet phototherapy unit, professional

Handisol - 00850054882066

UVB-150-2
DAAVLIN DISTRIBUTING CO., THE
Handisol
In Commercial Distribution

  • 00850054882066 ()


  • Ultraviolet phototherapy unit, professional

Handisol - 00850054882059

UVB-150-1
DAAVLIN DISTRIBUTING CO., THE
Handisol
In Commercial Distribution

  • 00850054882059 ()


  • Ultraviolet phototherapy unit, professional

Dermalume - 00850054882042

UVB-090
DAAVLIN DISTRIBUTING CO., THE
Dermalume
In Commercial Distribution

  • 00850054882042 ()


  • Ultraviolet phototherapy unit, professional

Zerigo Handheld System - 00865522000415

The Zerigo Home Light Therapy System treats chronic dermatological diseases such as Psoriasis, Vitiligo and Eczema.
Zerigo Health, Inc.
HD-02
In Commercial Distribution

  • 00865522000415 ()
HD-02

  • Ultraviolet phototherapy unit, professional

Spectrum Laser/IPL - 00860564000317

No Description
ROHRER AESTHETICS, LLC
Spectrum
In Commercial Distribution

  • 00860564000317 ()


  • Multi-modality skin surface treatment system generator

Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio - 00869164000086

Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Fujirebio Diagnostics, Inc.
CL0073
In Commercial Distribution

  • 00869164000086 ()


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay

Zerigo Handheld System - 00865522000422

Patient access use to the Zerigo Home Light Therapy System, including the provision of the light-emitting device, for the treatment of chronic dermatological conditions such as Psoriasis, Vitiligo, and Eczema for a limited utilization period.
Zerigo Health, Inc.
HD-02
In Commercial Distribution

HD-02-1

  • Ultraviolet phototherapy unit, professional
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