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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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Vision-S 700 is a Compact Refraction System used to determine the refractive error and binocular
ESSILOR INTERNATIONAL
VS01012
In Commercial Distribution

  • 03615020000687 ()


  • Phoropter, electric
Vision-C 600 (VRS001) is a visual chart system, stand-alone type, which displays broad range of charts, based on LCD panel.
ESSILOR INTERNATIONAL
VRS001
In Commercial Distribution

  • 03615020000670 ()


  • Visual acuity light box
Stereomicroscopic observation of the eye subjected to light through a slot Microscopic study of the fundus and posterior vitreous (via a lens Hubry) The ophthalmic evaluation and positioning of the contact lens This product is used by ophthalmologists and opticians (in their professional skills) to perform specific diagnostics in ophthalmology (biomicroscopy of the eye).
ESSILOR INTERNATIONAL
SL550L
In Commercial Distribution

  • 03615020000366 ()


  • Ophthalmic examination slit lamp
Stereomicroscopic observation of the eye subjected to light through a slot Microscopic study of the fundus and posterior vitreous (via a lens Hubry) The ophthalmic evaluation and positioning of the contact lens This product is used by ophthalmologists and opticians (in their professional skills) to perform specific diagnostics in ophthalmology (biomicroscopy of the eye).
ESSILOR INTERNATIONAL
SL500L
In Commercial Distribution

  • 03615020000359 ()


  • Ophthalmic examination slit lamp
Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
ESSILOR INTERNATIONAL
SL300L
Not in Commercial Distribution

  • 03615020000281 ()


  • Ophthalmic examination slit lamp
Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
ESSILOR INTERNATIONAL
SL300H
Not in Commercial Distribution

  • 03615020000274 ()


  • Ophthalmic examination slit lamp
Retina 400 is an electromedical system that allows for digitally retrieving, acquiring and processing of a retinal image, for use in ophthalmological diagnosis by medical specialists, and other uses inherent to the professional activity of other operators, optometrists and opticians, to the extent permitted by the laws and regulations for the exercise of their profession. An absolute new entry in the field for retinal imaging, the instrument allows for a direct, "live" monitoring on the computer screen, and capturing also in cases where the pupil diameter is extremely narrow. The instrument, with manual acquisition and electronically guided control, guarantees high precision and repeatability of the measurements.
ESSILOR INTERNATIONAL
RETINA 400
In Commercial Distribution

  • 03615020000267 ()


  • Ophthalmic fundus camera
This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed lens, processed framed lens and contact lens, and to put dots on them to find its axis. It also performs automatic discrimination of progressive lens, pupillary distance (PD) measurement of glass lens, UV cut percentage measurement, blue light which harmful to eyes cut percentage measurement, blue light transmittance measurement which necessary to adjust the circadian rhythm
ESSILOR INTERNATIONAL
ALM800
In Commercial Distribution

  • 03615020000236 ()


  • Automated lensmeter
Neuronaute - IceAdapter is a cable that enables to plug the Neuronaute IceCap electrodes with another DB25 cable and be connected to a compatible EEG monitoring system.
BIOSERENITY MEDICAL DEVICES GROUP
1001-15020-US
Not in Commercial Distribution

  • 03615220003471 ()


  • Electroencephalographic electrode cap, single-use
It enables the connection of the Neuronaute Head Module and the Neuronaute High Capacity battery module to the Neuronaute IceCap or a specific set of reusable cup electrodes manufactured with Ag/AgCl discs connected to a lead wire. The wire is insulated and terminates with a touch proof connector (DIN 42802)
BIOSERENITY MEDICAL DEVICES GROUP
1001-15015-US
Not in Commercial Distribution

  • 03615220001781 ()


  • Electroencephalographic monitoring system
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