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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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Lumipulse G B-Amyloid 1-42-N Plasma IRC
FUJIREBIO INC.
235447
In Commercial Distribution

  • 04987270235447 ()

  • 42 Tests per Kit


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay
Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue (skin).
Asclepion Laser Technologies GmbH
M18-4300-000
In Commercial Distribution

  • 04058784002624 ()


  • Multi-modality skin surface treatment system generator
Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue (skin).
Asclepion Laser Technologies GmbH
M18-4200-000
In Commercial Distribution

  • 04058784002617 ()


  • Multi-modality skin surface treatment system generator
Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue (skin).
Asclepion Laser Technologies GmbH
1823
In Commercial Distribution

  • 04058784000224 ()


  • Multi-modality skin surface treatment system generator
Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue (skin).
Asclepion Laser Technologies GmbH
1821
In Commercial Distribution

  • 04058784000088 ()


  • 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
1540 HANDPIECE ICON, REMANUFACTURED
Cynosure, LLC
2520D-1540R
In Commercial Distribution

  • 00841494102272 ()


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

  • 08631720003020 ()
LightPod Era

  • Multi-modality skin surface treatment system generator
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