Home GUDID 00853704002029 iStent
Primary DI 00853704002029
Brand iStent
Company GLAUKOS CORPORATION
Model GTS100i
Catalog number GTS100i
Device description Trabecular Micro-bypass Inserter
Published 2015-09-21
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 00853704002029 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 00853704002029 00853704002029 853704002029 0853704002029
GMDN Terms# Term, Definition table Term Definition Glaucoma micro-stent A 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 012835406 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 From This Company# Other Devices Sharing Product Codes# 
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