Home GUDID 20867487000138 Hydrus® Microstent
Primary DI 20867487000138
Brand Hydrus® Microstent
Company IVANTIS, 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
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name OGO Intraocular Pressure Lowering Implant
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OGO Intraocular Pressure Lowering Implant Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10867487000131 Package GS1 5 In Commercial Distribution 20867487000138 Package GS1 6 In Commercial Distribution 00867487000134 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 10867487000131 10867487000131 20867487000138 20867487000138 00867487000134 00867487000134 867487000134 0867487000134
GMDN Terms# Term, Definition table Term Definition Glaucoma micro-stent A sterile, 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 included.
Regulatory Flags# DUNS number 117203550 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices Sharing Product Codes# 
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