iStent inject W G2-W

GUDID 00853704002319

Trabecular Micro-Bypass System

GLAUKOS CORPORATION

Glaucoma micro-stent
Primary Device ID00853704002319
NIH Device Record Keyd893293c-868c-41e9-881c-857372701437
Commercial Distribution StatusIn Commercial Distribution
Brand NameiStent inject W
Version Model NumberG2-W
Catalog NumberG2-W
Company DUNS012835406
Company NameGLAUKOS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com
Phone949-367-9600
EmailQuality@glaukos.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100853704002319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OGOIntraocular Pressure Lowering Implant

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-19
Device Publish Date2020-08-11

Devices Manufactured by GLAUKOS CORPORATION

00853704002449 - iStent Infinite2022-10-27 Trabecular Micro-Bypass System
00853704002470 - iStent infinite2022-10-13 Trabecular Micro-Bypass System
00853704002456 - iPRIME2022-05-23 Viscodelivery System
00853704002463 - iAccess2022-05-23 Trabecular Trephine
00853704002319 - iStent inject W2020-08-19Trabecular Micro-Bypass System
00853704002319 - iStent inject W2020-08-19 Trabecular Micro-Bypass System
00853704002005 - iStent2019-09-12 Trabecular Micro-bypass Stent System - Right
00853704002012 - iStent2019-09-12 Trabecular Micro-bypass stent system - Left
00853704002029 - iStent2019-09-12 Trabecular Micro-bypass Inserter

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