iStent GTS100i
GUDID 00853704002029
Trabecular Micro-bypass Inserter
Glaukos Corporation
Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent Glaucoma micro-stent| Primary Device ID | 00853704002029 |
| NIH Device Record Key | ee7fa8fc-1b7c-4702-93b6-ef69aa6f6d47 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iStent |
| Version Model Number | GTS100i |
| Catalog Number | GTS100i |
| Company DUNS | 012835406 |
| Company Name | Glaukos Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com | |
| Phone | 949-367-9600 |
| Quality@glaukos.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853704002029 [Primary] |
FDA Product Code
| OGO | Intraocular Pressure Lowering Implant |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-09-12 |
| Device Publish Date | 2015-09-21 |
On-Brand Devices [iStent]
| 00853704002029 | Trabecular Micro-bypass Inserter |
| 00853704002012 | Trabecular Micro-bypass stent system - Left |
| 00853704002005 | Trabecular Micro-bypass Stent System - Right |
Trademark Results [iStent]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ISTENT 78285309 3077389 Live/Registered |
Glaukos Corporation 2003-08-08 |
 ISTENT 78282450 3008053 Dead/Cancelled |
Glaukos Corporation 2003-08-08 |
 ISTENT 77832287 3784386 Live/Registered |
Glaukos Corporation 2009-09-22 |
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