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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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7 Series DT 311-8, 110-120V, 60Hz
DAAVLIN DISTRIBUTING CO., THE
7 Series
In Commercial Distribution

  • 00850054882189 ()


  • Ultraviolet phototherapy unit, professional
7 Series DT 311-4, 110-120V, 60Hz
DAAVLIN DISTRIBUTING CO., THE
7 Series
In Commercial Distribution

  • 00850054882172 ()


  • Ultraviolet phototherapy unit, professional
4 Series DT 311-4, 120-240V, 50/60Hz
DAAVLIN DISTRIBUTING CO., THE
4 Series
In Commercial Distribution

  • 00850054882165 ()


  • Ultraviolet phototherapy unit, professional
1 Series DT 311-4, 120-240V, 50/60Hz
DAAVLIN DISTRIBUTING CO., THE
1 Series
In Commercial Distribution

  • 00850054882158 ()


  • Ultraviolet phototherapy unit, professional
UVB-680
DAAVLIN DISTRIBUTING CO., THE
Panosol 6-3D
In Commercial Distribution

  • 00850054882141 ()


  • Ultraviolet phototherapy unit, professional
UVB-612
DAAVLIN DISTRIBUTING CO., THE
Panosol 6-3D
In Commercial Distribution

  • 00850054882134 ()


  • Ultraviolet phototherapy unit, professional
UVA-680
DAAVLIN DISTRIBUTING CO., THE
Panosol 6-3D
In Commercial Distribution

  • 00850054882127 ()


  • Ultraviolet phototherapy unit, professional
UVA-612
DAAVLIN DISTRIBUTING CO., THE
Panosol 6-3D
In Commercial Distribution

  • 00850054882110 ()


  • Ultraviolet phototherapy unit, professional
UVB-660
DAAVLIN DISTRIBUTING CO., THE
Panosol 6
In Commercial Distribution

  • 00850054882103 ()


  • Ultraviolet phototherapy unit, professional
UVB-640
DAAVLIN DISTRIBUTING CO., THE
Panosol 6
In Commercial Distribution

  • 00850054882097 ()


  • Ultraviolet phototherapy unit, professional
UVA-660
DAAVLIN DISTRIBUTING CO., THE
Panosol 6
In Commercial Distribution

  • 00850054882080 ()


  • Ultraviolet phototherapy unit, professional
UVA-640
DAAVLIN DISTRIBUTING CO., THE
Panosol 6
In Commercial Distribution

  • 00850054882073 ()


  • Ultraviolet phototherapy unit, professional
UVB-150-2
DAAVLIN DISTRIBUTING CO., THE
Handisol
In Commercial Distribution

  • 00850054882066 ()


  • Ultraviolet phototherapy unit, professional
UVB-150-1
DAAVLIN DISTRIBUTING CO., THE
Handisol
In Commercial Distribution

  • 00850054882059 ()


  • Ultraviolet phototherapy unit, professional
UVB-090
DAAVLIN DISTRIBUTING CO., THE
Dermalume
In Commercial Distribution

  • 00850054882042 ()


  • Ultraviolet phototherapy unit, professional
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
No Description
ROHRER AESTHETICS, LLC
Spectrum
In Commercial Distribution

  • 00860564000317 ()


  • Multi-modality skin surface treatment system generator
medical aesthetic laser for skin resurfacing
AEROLASE CORPORATION
ErbiumXL
In Commercial Distribution

  • 00863172000311 ()


  • Multi-modality skin surface treatment system generator
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
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
The Clarify Home Light Therapy System treats chronic dermatological diseases such as Psoriasis, Vitiligo and Eczema.
Zerigo Health, Inc.
HD-01
In Commercial Distribution

  • 00865522000408 ()
HD-01

  • Ultraviolet phototherapy unit, professional
PEG Safety Kit Push Technique
CORPAK MEDSYSTEMS, INC.
30-4320-S7
In Commercial Distribution

  • 20815149025357 ()
  • 10815149025350 ()

  • 20 FR (6.7mm)
  • Catheter Gauge: 20 French
30-4320-S7

  • Ultraviolet phototherapy unit, professional
PEG Kit Push Technique; with snare
CORPAK MEDSYSTEMS, INC.
30-4020-S7
In Commercial Distribution

  • 20815149025340 ()
  • 10815149025343 ()

  • 20 FR (6.7mm)
  • Catheter Gauge: 20 French
30-4020-S7

  • Ultraviolet phototherapy unit, professional
PEG Safety Kit Push Technique
CORPAK MEDSYSTEMS, INC.
30-4320
In Commercial Distribution

  • 20815149024060 ()
  • 10815149024063 ()

  • 20 FR (6.7mm)
  • Catheter Gauge: 20 French
30-4320

  • Ultraviolet phototherapy unit, professional
PEG Kit with ENFit connectors Push Technique
CORPAK MEDSYSTEMS, INC.
50-4020E1
In Commercial Distribution

  • 20815149021816 ()
  • 10815149021819 ()

  • 20 FR (6.7mm)
  • Catheter Gauge: 20 French
50-4020E1

  • Ultraviolet phototherapy unit, professional
PEG Safety Kit with ENFit Connectors Push Technique
CORPAK MEDSYSTEMS, INC.
50-4320-S7
In Commercial Distribution

  • 20815149021465 ()
  • 10815149021468 ()

  • 20 FR (6.7mm)
  • Catheter Gauge: 20 French
50-4320-S7

  • Ultraviolet phototherapy unit, professional
PEG Safety Kit with ENFit Connectors Push Technique
CORPAK MEDSYSTEMS, INC.
50-4320
In Commercial Distribution

  • 20815149021458 ()
  • 10815149021451 ()

  • 20 FR (6.7mm)
  • Catheter Gauge: 20 French
50-4320

  • Ultraviolet phototherapy unit, professional
PEG Kit with ENFit connectors Push Technique; with snare
CORPAK MEDSYSTEMS, INC.
50-4020-S7
In Commercial Distribution

  • 20815149021441 ()
  • 10815149021444 ()

  • 20 FR (6.7mm)
  • Catheter Gauge: 20 French
50-4020-S7

  • Ultraviolet phototherapy unit, professional
Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) telangiectasias (532 nm) spider nevi (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles (532 nm) nevus of ota (1064 nm)
Daeju Medi Tech Engineering
1.0
In Commercial Distribution

  • 08800017500102 ()
DJMD0004

  • Multi-modality skin surface treatment system generator
Exci308® by Aerolase This medical device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. Excimer light source, wavelength 308nm, optical power 2500 mW.
CLARTEIS
EIPL-100
In Commercial Distribution

  • 03760313461017 ()
EIPL-PRD-K01-exci308

  • Ultraviolet phototherapy unit, professional
Exciplex® set - USA This medical device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. Excimer light source, wavelength 308nm, optical power 2500 mW.
CLARTEIS
EIPL-100
In Commercial Distribution

  • 03760313461000 ()
EIPL-PRD-K01-(US)

  • Ultraviolet phototherapy unit, professional
No Description
QUANTA SYSTEM SPA
EAM001274
Not in Commercial Distribution

  • 08033945934767 ()


  • Multi-modality skin surface treatment system generator
No Description
QUANTA SYSTEM SPA
PZMS00013
Not in Commercial Distribution

  • 08033945934750 ()


  • Multi-modality skin surface treatment system generator
No Description
QUANTA SYSTEM SPA
PZMS00012
Not in Commercial Distribution

  • 08033945934668 ()


  • Multi-modality skin surface treatment system generator
No Description
QUANTA SYSTEM SPA
PZMS00011
Not in Commercial Distribution

  • 08033945934651 ()


  • Multi-modality skin surface treatment system generator
1540 HANDPIECE ICON, REMANUFACTURED
Cynosure, LLC
2520D-1540R
In Commercial Distribution

  • 00841494102272 ()


  • Multi-modality skin surface treatment system generator
ASSY, 1540 HANDPIECE, ICON
Cynosure, LLC
2520D-1540
In Commercial Distribution

  • 00841494100520 ()


  • Multi-modality skin surface treatment system generator
ICON CONTROL MODULE REMAN
Cynosure, LLC
2520-0003R
In Commercial Distribution

  • 00841494103774 ()


  • Multi-modality skin surface treatment system generator
Medical Aesthetic Laser for skin resurfacing
AEROLASE CORPORATION
ErbiumXL
Not in Commercial Distribution

  • 08631720003020 ()
LightPod Era

  • Multi-modality skin surface treatment system generator
The Enhanced AURORA™ Medical Diode system and related accessories is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis, eczema, and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.
PSORIA-SHIELD INC.
2000
In Commercial Distribution

  • B780AUR20000 ()


  • Ultraviolet phototherapy unit, professional
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