DEVICE: iStent inject (00853704002203)
Device Identifier (DI) Information
iStent inject
G2-M-IS
In Commercial Distribution
G2-M-IS
GLAUKOS CORPORATION
G2-M-IS
In Commercial Distribution
G2-M-IS
GLAUKOS CORPORATION
Trabecular Micro-Bypass System
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
62945 | 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.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OGO | Intraocular Pressure Lowering Implant |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P170043 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
0d2ca507-6b9c-40de-a612-497457778fed
June 09, 2025
5
July 25, 2018
June 09, 2025
5
July 25, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
949-367-9600
Quality@glaukos.com
Quality@glaukos.com