Home GUDID 00813359020007 KAMRA inlay
Primary DI 00813359020007
Brand KAMRA inlay
Company Bausch & Lomb Incorporated
Model 76043
Device description Carton Assembly, ACI 7000
Published 2015-04-29
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name LQE Implant, Corneal, Refractive
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LQE Implant, Corneal, Refractive Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00813359020007 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00813359020007 00813359020007 813359020007 0813359020007
GMDN Terms# Term, Definition table Term Definition Corneal inlay, aperture reducing A sterile implantable device inserted into the natural cornea to treat presbyopia [age-related hyperopia (far sightedness)] based on aperture reduction. It is typically made of plastic material and is shaped as a thin annulus (disc) formed to fit the curvature of the cornea; it includes a central opening that restricts the optical aperture of the eye to increase depth of field. It is intended for long-term implantation and is surgically inserted in an intrastromal pocket or flap made by a keratome or an appropriate laser.
Regulatory Flags# DUNS number 196603781 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850048576100 Intacs for Keratoconus, Symmetric 0.210 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576117 Intacs for Keratoconus, Symmetric 0.250 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576124 Intacs for Keratoconus, Symmetric 0.300 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576131 Intacs for Keratoconus, Symmetric 0.350 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576148 Intacs for Keratoconus, Symmetric 0.400 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576155 Intacs for Keratoconus, Symmetric 0.450 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576162 Intacs for Keratoconus, Asymmetric 0.210/0.350 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576179 Intacs for Keratoconus, Asymmetric 0.210/0.400 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576186 Intacs for Keratoconus, Asymmetric 0.210/0.450 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576193 Intacs for Myopia, Symmetric 0.250 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576209 Intacs for Myopia, Symmetric 0.300 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576216 Intacs for Myopia, Symmetric 0.350 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00813359020052 KAMRA inlay Bausch & Lomb Incorporated LQE 2017-01-13 00813359020045 KAMRA inlay Bausch & Lomb Incorporated LQE 2017-01-05 10850394006013 Raindrop Near Vision Inlay REVISION OPTICS, INC. LQE 2016-08-19 10850394006051 Inlay Inserter Chuck Handle REVISION OPTICS, INC. LQE 2016-08-19 00866304000104 Intacs Corneal Implants ADDITION TECHNOLOGY, INC. LQE 2015-06-30