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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

INTELLANAV STABLEPOINT™ - 08714729992240

Ablation Catheter
BOSTON SCIENTIFIC CORPORATION
M004RFSDS9620K20
In Commercial Distribution

  • 08714729992240 ()

  • 4 mm catheter tip electrode length
  • 8F (2.67mm) ring electrodes
M004RFSDS9620K20

  • Cardiac radio-frequency ablation system catheter

INTELLANAV STABLEPOINT™ - 08714729992233

Ablation Catheter
BOSTON SCIENTIFIC CORPORATION
M004RFSDS96200
In Commercial Distribution

  • 08714729992233 ()

  • 8F (2.67mm) ring electrodes
  • 4 mm catheter tip electrode length
M004RFSDS96200

  • Cardiac radio-frequency ablation system catheter

QDOT MICRO - 10846835017106

Uni-Directional Navigation Catheter, NAV, J
Biosense Webster Inc
D139403
In Commercial Distribution

  • 10846835017106 ()
D139403

  • Cardiac radio-frequency ablation system catheter

QDOT MICRO - 10846835017076

Uni-Directional Navigation Catheter, NAV, F
Biosense Webster Inc
D139402
In Commercial Distribution

  • 10846835017076 ()
D139402

  • Cardiac radio-frequency ablation system catheter

QDOT MICRO - 10846835017045

Uni-Directional Navigation Catheter, NAV, D
Biosense Webster Inc
D139401
In Commercial Distribution

  • 10846835017045 ()
D139401

  • Cardiac radio-frequency ablation system catheter

QDOT MICRO - 10846835016758

Bi-Directional Navigation Catheter, NAV, D-F
Biosense Webster Inc
D139505
In Commercial Distribution

  • 10846835016758 ()
D139505

  • Cardiac radio-frequency ablation system catheter

QDOT MICRO - 10846835016741

Bi-Directional Navigation Catheter, NAV, F-J
Biosense Webster Inc
D139504
In Commercial Distribution

  • 10846835016741 ()
D139504

  • Cardiac radio-frequency ablation system catheter

QDOT MICRO - 10846835016734

Bi-Directional Navigation Catheter, NAV, J-J
Biosense Webster Inc
D139503
In Commercial Distribution

  • 10846835016734 ()
D139503

  • Cardiac radio-frequency ablation system catheter

QDOT MICRO - 10846835016727

Bi-Directional Navigation Catheter, NAV, F-F
Biosense Webster Inc
D139502
In Commercial Distribution

  • 10846835016727 ()
D139502

  • Cardiac radio-frequency ablation system catheter
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