Home GUDID 00866304000104 Intacs Corneal Implants
Primary DI 00866304000104
Brand Intacs Corneal Implants
Company ADDITION TECHNOLOGY, INC.
Model ICI
Device description An implantable arc designed to flatten the anterior corneal curvature, without disturbing the visual axis, to correct certain corneal-related visual disorders. The medical device is a plastic arc, of about 150 degrees, that is inserted into the cornea via an intrastromal channel. It is typically available in sizes from 0.250 to 0.450 mm.
Published 2015-06-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 00866304000104 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 00866304000104 00866304000104 866304000104 0866304000104
GMDN Terms# Term, Definition table Term Definition Intracorneal ring segment An implantable arc designed to flatten the anterior corneal curvature, without disturbing the visual axis, to correct certain corneal-related visual disorders. It is typically a plastic arc, of about 150 degrees and provided in pairs, inserted into the cornea via an intrastromal channel created with a diamond knife or laser, and that can be implanted away from the radial incision to minimize complications. It is typically available in sizes from 0.25 to 0.35 mm. The device is intended to correct mild and moderate myopia and to treat patients with irregular astigmatism as a result of keratoconus, especially those who can no longer benefit from contact lenses or spectacles.
Regulatory Flags# DUNS number 118496814 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850048576001 Intacs Corneal Separator, CW, 0.9mm KV10730-1 2023-06-13 00850048576018 Intacs Corneal Separator, CCW, 0.9mm KV10730-2 2023-06-13 00850048576025 Intacs Inspection Gauge KV10732 2023-06-13 00850048576032 Intacs Procedure Marker KV10733 2023-06-13 00850048576049 Intacs Forceps KV10445 2023-06-13 00850048576056 Intacs Vacuum Centering Guide KV10478-2 2023-06-13 00850048576063 Intacs Pocketing Hook KV10606 2023-06-13 00850048576070 Intacs Symmetric Glide KV1160 2023-06-13 00850048576100 Intacs for Keratoconus, Symmetric 0.210 mm ICI-210-150 11600-210-150 2023-06-13 00850048576117 Intacs for Keratoconus, Symmetric 0.250 mm ICI-250-150 11600-250-150 2023-06-13 00850048576124 Intacs for Keratoconus, Symmetric 0.300 mm ICI-300-150 11600-300-150 2023-06-13 00850048576131 Intacs for Keratoconus, Symmetric 0.350 mm ICI-350-150 11600-350-150 2023-06-13 00850048576148 Intacs for Keratoconus, Symmetric 0.400 mm ICI-400-150 11600-400-150 2023-06-13 00850048576155 Intacs for Keratoconus, Symmetric 0.450 mm ICI-450-150 11600-450-150 2023-06-13 00850048576162 Intacs for Keratoconus, Asymmetric 0.210/0.350 mm ICIA-210/350-150 11400-210/350-150 2023-06-13 00850048576179 Intacs for Keratoconus, Asymmetric 0.210/0.400 mm ICIA-210/400-150 11400-210/400-150 2023-06-13 00850048576186 Intacs for Keratoconus, Asymmetric 0.210/0.450 mm ICIA-210/450-150 11400-210/450-150 2023-06-13 00850048576193 Intacs for Myopia, Symmetric 0.250 mm ICI-250-150 11700-250-150 2023-06-13 00850048576209 Intacs for Myopia, Symmetric 0.300 mm ICI-300-150 11700-300-150 2023-06-13 00850048576216 Intacs for Myopia, Symmetric 0.350 mm ICI-350-150 11700-350-150 2023-06-13
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 00813359020007 KAMRA inlay Bausch & Lomb Incorporated LQE 2015-04-29