FDA.reportPublic FDA data

Hydrus® Microstent

Primary DI
00867487000134
Brand
Hydrus® Microstent
Company
Alcon Laboratories, Inc.
Model
F00022
Catalog number
F00022
Device description
Hydrus® Microstent
Published
2018-08-15
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
CodeName
OGOIntraocular Pressure Lowering Implant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGOIntraocular Pressure Lowering ImplantUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10867487000131PackageGS15In Commercial Distribution
20867487000138PackageGS16In Commercial Distribution
00867487000134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086748700013110867487000131
2086748700013820867487000138
00867487000134008674870001348674870001340867487000134

GMDN Terms#

Term, Definition table
TermDefinition
Glaucoma micro-stentA non-bioabsorbable device designed to be implanted in Schlemm’s canal (within the eye) for the restoration of aqueous humour outflow and subsequent reduction of intraocular pressure as part of treatment for open angle glaucoma. It is a metallic device which may be intended to dilate, support, and/or create a channel into Schlemm’s canal; disposable devices associated with implantation (e.g., delivery system) may be packaged with the stent.

Regulatory Flags#

DUNS number
008018525
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380657530021ORA SYSTEM, VerifEye80657530022026-07-22
00380657530274LEGION80657530272026-07-22
00380657530281LEGION80657530282026-07-22
00380657530298LEGION, INTREPID80657530292026-07-22
00380657530373LEGION80657530372026-07-22
00380657530502LEGION80657530502026-07-22
00380657530564LEGION80657530562026-07-22
00380657530755LEGION80657530752026-07-22
00380657530892LEGION80657530892026-07-22
00380657531639LEGION, KELMAN80657531632026-07-22
00380657531646LEGION, KELMAN80657531642026-07-22
00380657531653LEGION, INTREPID, KELMAN80657531652026-07-22
00380657531660LEGION, INTREPID, KELMAN80657531662026-07-22
00380659983313ORA SYSTEM, VerifEye80659983312026-07-22
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00853704002487iStent inject W Trabecular Micro-Bypass System with Infinite Injector TechnologyGLAUKOS CORPORATIONOGO2025-04-30
00853704002319iStent inject WGLAUKOS CORPORATIONOGO2020-08-11
20867487000138Hydrus® MicrostentIVANTIS, INC.OGO2018-08-15
00853704002203iStent injectGLAUKOS CORPORATIONOGO2018-07-25
00380657540075CypassAlcon Laboratories, Inc.OGO2018-07-19
00380657540037CyPassAlcon Laboratories, Inc.OGO2016-09-16
10380657540034CyPassAlcon Laboratories, Inc.OGO2016-09-16
00853704002005iStentGLAUKOS CORPORATIONOGO2015-09-21
00853704002012iStentGLAUKOS CORPORATIONOGO2015-09-21
00853704002029iStentGLAUKOS CORPORATIONOGO2015-09-21