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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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SEDASYS - 20705036003783

ECG Cable AAMI Color Std
ETHICON ENDO-SURGERY, INC.
SEDECAMI
Not in Commercial Distribution

  • 30705036003780 ()
  • 20705036003783 ()
SEDECAMI

  • Intraprocedural physiologic-monitoring sedation system

SEDASYS - 20705036003776

ECG Leads AAMI Color Std
ETHICON ENDO-SURGERY, INC.
SEDE3AMI
Not in Commercial Distribution

  • 30705036003773 ()
  • 20705036003776 ()
SEDE3AMI

  • Intraprocedural physiologic-monitoring sedation system

SEDASYS - 20705036003615

NIBP Cuff - Adult Small
ETHICON ENDO-SURGERY, INC.
SEDBPSM
Not in Commercial Distribution

  • 30705036003612 ()
  • 20705036003615 ()
SEDBPSM

  • Intraprocedural physiologic-monitoring sedation system

SEDASYS - 20705036003608

NIBP Cuff - Adult Thigh
ETHICON ENDO-SURGERY, INC.
SEDBPAP
Not in Commercial Distribution

  • 30705036003605 ()
  • 20705036003608 ()
SEDBPAP

  • Intraprocedural physiologic-monitoring sedation system

SEDASYS - 20705036003592

NIBP Cuff - Adult Large
ETHICON ENDO-SURGERY, INC.
SEDBPAL
Not in Commercial Distribution

  • 30705036003599 ()
  • 20705036003592 ()
SEDBPAL

  • Intraprocedural physiologic-monitoring sedation system

SEDASYS - 20705036003585

NIBP Cuff - Adult
ETHICON ENDO-SURGERY, INC.
SEDBPA
Not in Commercial Distribution

  • 30705036003582 ()
  • 20705036003585 ()
SEDBPA

  • Intraprocedural physiologic-monitoring sedation system

SEDASYS - 20705036003578

NIBP Extension
ETHICON ENDO-SURGERY, INC.
SEDBP6EC
Not in Commercial Distribution

  • 30705036003575 ()
  • 20705036003578 ()
SEDBP6EC

  • Intraprocedural physiologic-monitoring sedation system

SEDASYS - 20705036003561

SEDASYS AUTOMATED RESPONSIVENESS MONITOR
ETHICON ENDO-SURGERY, INC.
SEDARM01
Not in Commercial Distribution

  • 30705036003568 ()
  • 20705036003561 ()
SEDARM01

  • Intraprocedural physiologic-monitoring sedation system

SEDASYS - 20705036003554

SEDASYS UMBILICAL CABLE
ETHICON ENDO-SURGERY, INC.
SED8UC
Not in Commercial Distribution

  • 30705036003551 ()
  • 20705036003554 ()
SED8UC

  • Intraprocedural physiologic-monitoring sedation system

VISUMAX - 04049471095111

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
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