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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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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
Vision-R 700 is intended to perform a subjective assessment of ametropia or visual function capability
ESSILOR INTERNATIONAL
V01114
In Commercial Distribution

  • 03615020000724 ()


  • Phoropter, electric
Vision-R 800 is intended to perform a subjective assessment of ametropia or visual function capability
ESSILOR INTERNATIONAL
V01014
In Commercial Distribution

  • 03615020000694 ()


  • Phoropter, electric
Vision-R 700 is intended to perform a subjective assessment of ametropia or visual function capability
ESSILOR INTERNATIONAL
V01112
In Commercial Distribution

  • 03615020000663 ()


  • Phoropter, electric
3D Optical Coherence Tomography OCT500 is a non-contact, high-resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging, and measurement of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, ganglion cell complex, macula, optic nerve head. It is also indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging of anterior ocular structures, including the cornea. The instrument is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, agerelated macular degeneration, and glaucoma.
ESSILOR INTERNATIONAL
OCT2JT
In Commercial Distribution

  • 03615020000489 ()


  • Retinal optical coherence tomography system
Retina 800 is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent
ESSILOR INTERNATIONAL
RET1IN
In Commercial Distribution

  • 03615020000465 ()


  • Ophthalmic fundus camera
Vision-R 800 is intended to perform a subjective assessment of ametropia or visual function capability
ESSILOR INTERNATIONAL
V01012
In Commercial Distribution

  • 03615020000427 ()


  • Phoropter, electric
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