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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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The VISUMAX is a femtosecond laser. It generates a beam of ultra-short laser pulses which are guided through the aperture in the treatment objective . The optical system focuses the laser beam into the corneal tissue. The VISUMAX Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia with or without astigmatism • for spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters, • for cylinder from -0.75 diopters through -3.00 diopters, • when refraction spherical equivalent is no greater in magnitude than 10.00 diopters, in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of lower or equal 0.50 D in magnitude.
Carl Zeiss Meditec AG
VISUMAX 800 or 09511
In Commercial Distribution

  • 04049471095111 ()

  • Weight: 520 Kilogram
  • LxW 1.71m x0.925


  • Femtosecond ophthalmic solid-state laser system
FREEDOM BTE RECHARGEABLE BATTERY, BROWN
COCHLEAR LIMITED
Z61021
In Commercial Distribution

  • 09321502029247 ()
Z61021

  • Secondary battery
  • Portable/mobile rechargeable battery pack
Neurostimulator 3058 US InterStim 2
MEDTRONIC, INC.
3058
Not in Commercial Distribution

  • 00613994287724 ()


  • Implantable incontinence-control electrical stimulation system pulse generator
EXT 3095-51 QD INLINE 51CM BWL MRI-HC US
MEDTRONIC, INC.
3095-51
Not in Commercial Distribution

  • 00643169013438 ()

  • Length: 51.0 Centimeter


  • Neural-tissue electrical stimulation lead adaptor
EXT 3095-25 QD INLINE 25CM BWL MRI-HC US
MEDTRONIC, INC.
3095-25
Not in Commercial Distribution

  • 00643169013421 ()

  • Length: 25.0 Centimeter


  • Neural-tissue electrical stimulation lead adaptor
EXT 3095-10 QD INLINE 10CM BWL MRI-HC US
MEDTRONIC, INC.
3095-10
Not in Commercial Distribution

  • 00643169013414 ()

  • Length: 10.0 Centimeter


  • Neural-tissue electrical stimulation lead adaptor
EXT 3095-51 QD INLNE 51CM BWL MRI-HC EMN
MEDTRONIC, INC.
3095-51
Not in Commercial Distribution

  • 00643169346277 ()

  • Length: 51.0 Centimeter


  • Neural-tissue electrical stimulation lead adaptor
EXT 3095-25 QD INLNE 25CM BWL MRI-HC EMN
MEDTRONIC, INC.
3095-25
Not in Commercial Distribution

  • 00643169346260 ()

  • Length: 25.0 Centimeter


  • Neural-tissue electrical stimulation lead adaptor
EXT 3095-10 QD INLNE 10CM BWL MRI-HC EMN
MEDTRONIC, INC.
3095-10
Not in Commercial Distribution

  • 00643169346253 ()

  • Length: 10.0 Centimeter


  • Neural-tissue electrical stimulation lead adaptor
LEAD 309101 PNE TEST STIM KIT EMAN US
MEDTRONIC, INC.
309101
Not in Commercial Distribution

  • 00643169021457 ()


  • Sacral plexus percutaneous incontinence-control electrical stimulation system electrode
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