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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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VISIONIX - 03664188000039

The VX130+ is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefractometer, keratometer, corneal topographer, tonometer, multi-slit pachymeter, tear-film analyzer , and retro illumination. The VX130+ is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea. Full cornea thickness map Scheimpflug imaging Anterior chamber imaging Pupil Image Image of the cornea relative to the iris Analysis of the tear film and evaluation of tear film non-invasive tear break-up time (NITBUT) Meibomian glands imaging Evaluation of tear meniscus height
LUNEAU TECHNOLOGY OPERATIONS
VX130+
In Commercial Distribution

  • 03664188000039 ()


  • Automated ophthalmic refractometer
  • Optical pachymeter
  • Ophthalmic tonometer, battery-operated

VISIONIX - 03664188002200

The VX220 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: keratometer, corneal topographer, tonometer,and pachymeter and retro illumination
LUNEAU TECHNOLOGY OPERATIONS
VX220
In Commercial Distribution

  • 03664188002200 ()


  • Ophthalmic tonometer, battery-operated
  • Optical pachymeter

VISIONIX - 03664188001203

The VX120 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefracter keratometer, corneal topographer, tonometer, pachymeter and retro illumination.
LUNEAU TECHNOLOGY OPERATIONS
VX120
In Commercial Distribution

  • 03664188001203 ()


  • Automated ophthalmic refractometer
  • Optical pachymeter
  • Ophthalmic tonometer, battery-operated

VISIONIX - 03664188001180

The VX118 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefracter keratometer, corneal topographer, pachymeter and retro illumination.
LUNEAU TECHNOLOGY OPERATIONS
VX118
In Commercial Distribution

  • 03664188001180 ()


  • Optical pachymeter
  • Automated ophthalmic refractometer

VISIONIX - 03664188000909

The VX130 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea. Full cornea thickness map Scheimpflug imaging Anterior chamber imaging Pupil Image Image of the cornea relative to the iris
LUNEAU TECHNOLOGY OPERATIONS
VX130
In Commercial Distribution

  • 03664188000909 ()


  • Automated ophthalmic refractometer
  • Optical pachymeter
  • Ophthalmic tonometer, battery-operated

VISIONAIRE - 00885556583111

NON STERILE VISIONAIRE RIGHT CUTTING BLOCK KIT - JOURNEY BI CRUCIATE SYSTEM
Smith & Nephew, Inc.
V0200033
In Commercial Distribution

  • 00885556583111 ()
V0200033

  • Orthopaedic implant aiming/guiding block, reusable

VISIONAIRE - 00885556583104

NON STERILE VISIONAIRE LEFT CUTTING BLOCK KIT - JOURNEY BI CRUCIATE SYSTEM
Smith & Nephew, Inc.
V0200032
In Commercial Distribution

  • 00885556583104 ()
V0200032

  • Orthopaedic implant aiming/guiding block, reusable

VISIONAIRE - 00885556583098

NON STERILE VISIONAIRE PROXIMAL TIBIA CUTTING BLOCK - JOURNEY BI CRUCIATE SYSTEM
Smith & Nephew, Inc.
V0200031
In Commercial Distribution

  • 00885556583098 ()

  • 0
V0200031

  • Orthopaedic implant aiming/guiding block, reusable

VISIONAIRE - 00885556583081

NON STERILE VISIONAIRE DISTAL FEMUR CUTTING BLOCK - JOURNEY BCS
Smith & Nephew, Inc.
V0200030
In Commercial Distribution

  • 00885556583081 ()

  • 0
V0200030

  • Orthopaedic implant aiming/guiding block, reusable

VISIONAIRE - 00885556583074

NON STERILE VISIONAIRE RIGHT CUTTING BLOCK KIT - LEGION PRIMARY
Smith & Nephew, Inc.
V0200023
In Commercial Distribution

  • 00885556583074 ()
V0200023

  • Orthopaedic implant aiming/guiding block, reusable
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