Home GUDID M687PR00018000 Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz)
Primary DI M687PR00018000
Brand Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz)
Company VISIONCARE OPHTHALMIC TECHNOLOGIES LTD.
Model WA 2.2X
Catalog number PR00018-00
Published 2014-09-18
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name NCJ Telescope, Implantable, Miniature
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NCJ Telescope, Implantable, Miniature Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M687PR00018000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Intraocular telescope An implantable optical device designed to improve visual acuity in patients with bilateral moderate to profound central vision impairment due to age related macular degeneration. It is a non-active micro-Galilean telescope consisting of a doublet lens confined in a glass cylinder intended to replace the natural lens of the eye. The device functions together with the cornea as a telephoto system to render an enlarged image on the retina to improve vision. Disposable devices associated with implantation may be included with the lens.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 50.66 KiloPascal 121.59 KiloPascal Storage Environment Humidity 20 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 0 Degrees Celsius 43 Degrees Celsius
Regulatory Flags# DUNS number 532007614 Device count 1 Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M687PR00020000 Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz) WA 2.7X PR00020-00 2014-09-18 M687PR103013 Lens Exchange Sytem G23 PR00103-01 2017-06-01 M687PR104013 Lens Exchange Sytem G25 PR00104-01 2017-06-01
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published M687PR00020000 Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz) VISIONCARE OPHTHALMIC TECHNOLOGIES LTD. NCJ 2014-09-18
visioncareinc.net