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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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MEL 80 - 04049471000221

The MEL 80 Excimer Laser System is indicated for use in primary Laser Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of - myopia of less than or equal to -7.0 D with or without refractive astigmatism of less than or equal to -3.0 D, with a Maximum MRSE of -7.0 D - naturally occurring hyperopia of less than or equal to +5.0 D with or without refractive astigmatism of greater than +0.5 D and less than or equal to +3.0 D, with a maximum MRSE of +5.0 D in patients who are 21 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by Change in sphere and cylinder of 0.5 D.
Carl Zeiss Meditec AG
MEL 80
In Commercial Distribution

  • 04049471000221 ()

  • Weight: 260 Kilogram
  • LxWxH: 1.55m x 0.80m x1.49m


  • Ophthalmic excimer laser system

Stent - 00842429117903

LVIS EVO
MICROVENTION INC.
LEV4031-PMA
In Commercial Distribution

  • 00842429117903 ()

  • 4.0 mm x 31 mm
LEV4031

  • Bare-metal intracranial vascular stent

Stent - 00842429117897

LVIS EVO
MICROVENTION INC.
LEV4027-PMA
In Commercial Distribution

  • 00842429117897 ()

  • 4.0 mm x 27 mm
LEV4027

  • Bare-metal intracranial vascular stent

Stent - 00842429117880

LVIS EVO
MICROVENTION INC.
LEV4021-PMA
In Commercial Distribution

  • 00842429117880 ()

  • 4.0 mm x 21 mm
LEV4021

  • Bare-metal intracranial vascular stent

Stent - 00842429117873

LVIS EVO
MICROVENTION INC.
LEV4018-PMA
In Commercial Distribution

  • 00842429117873 ()

  • 4.0 mm x 18 mm
LEV4018

  • Bare-metal intracranial vascular stent

Stent - 00842429117866

LVIS EVO
MICROVENTION INC.
LEV4013-PMA
In Commercial Distribution

  • 00842429117866 ()

  • 4.0 mm x 13 mm
LEV4013

  • Bare-metal intracranial vascular stent

Stent - 00842429117859

LVIS EVO
MICROVENTION INC.
LEV3534-PMA
In Commercial Distribution

  • 00842429117859 ()

  • 3.5 mm x 34 mm
LEV3534

  • Bare-metal intracranial vascular stent

Stent - 00842429117842

LVIS EVO
MICROVENTION INC.
LEV3528-PMA
In Commercial Distribution

  • 00842429117842 ()

  • 3.5 mm x 28 mm
LEV3528

  • Bare-metal intracranial vascular stent

Stent - 00842429117835

LVIS EVO
MICROVENTION INC.
LEV3522-PMA
In Commercial Distribution

  • 00842429117835 ()

  • 3.5 mm x 22 mm
LEV3522

  • Bare-metal intracranial vascular stent

Stent - 00842429117828

LVIS EVO
MICROVENTION INC.
LEV3517-PMA
In Commercial Distribution

  • 00842429117828 ()

  • 3.5 mm x 17 mm
LEV3517

  • Bare-metal intracranial vascular stent
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