iStent inject G2-M-IS

GUDID 00853704002203

Trabecular Micro-Bypass System

Glaukos Corporation

Glaucoma micro-stent
Primary Device ID00853704002203
NIH Device Record Key0d2ca507-6b9c-40de-a612-497457778fed
Commercial Distribution StatusIn Commercial Distribution
Brand NameiStent inject
Version Model NumberG2-M-IS
Catalog NumberG2-M-IS
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
Phone949-367-9600
EmailQuality@glaukos.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100853704002203 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-09-12
Device Publish Date2018-07-25

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 W2020-08-19 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

Trademark Results [iStent inject]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ISTENT INJECT
ISTENT INJECT
77547418 4150413 Live/Registered
Glaukos Corporation
2008-08-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.