Home GUDID 00888628047474 XEN Glaucoma Treatment System
Primary DI 00888628047474
Brand XEN Glaucoma Treatment System
Company Allergan, Inc.
Model 5513-001
Catalog number 5513-001
Device description XEN Sterile Injector US
Published 2026-07-17
Public version status New
Distribution status 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 KYF Implant, Eye Valve
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KYF Implant, Eye Valve Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00888628047474 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 00888628047474 00888628047474 888628047474 0888628047474
GMDN Terms# Term, Definition table Term Definition Glaucoma shunt, tubular, animal-derived A non-bioabsorbable, implantable ocular tube that includes animal-derived materials (e.g., porcine) intended to create an artificial drainage channel for diversion of aqueous humour from the anterior chamber of the eye to reduce intraocular pressure (IOP) as an alternative to, or after failed, trabeculectomy, for the management of glaucoma. It is a gelatin tube introduced into the anterior chamber. Disposable devices associated with implantation may be packaged with the shunt.
Regulatory Flags# DUNS number 144796497 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10888628031432 Natrelle Inspira ST Resterilizable Sizers MSZST-L110 MSZST-L110 2016-10-04 10888628031449 Natrelle Inspira ST Resterilizable Sizers MSZST-L125 MSZST-L125 2016-10-04 10888628031456 Natrelle Inspira ST Resterilizable Sizers MSZST-L140 MSZST-L140 2016-10-04 10888628031463 Natrelle Inspira ST Resterilizable Sizers MSZST-L170 MSZST-L170 2016-10-04 10888628031470 Natrelle Inspira ST Resterilizable Sizers MSZST-L200 MSZST-L200 2016-10-04 10888628031487 Natrelle Inspira ST Resterilizable Sizers MSZST-L230 MSZST-L230 2016-10-04 10888628031494 Natrelle Inspira ST Resterilizable Sizers MSZST-L260 MSZST-L260 2016-10-04 10888628031500 Natrelle Inspira ST Resterilizable Sizers MSZST-L290 MSZST-L290 2016-10-04 10888628031517 Natrelle Inspira ST Resterilizable Sizers MSZST-L320 MSZST-L320 2016-10-04 10888628031524 Natrelle Inspira ST Resterilizable Sizers MSZST-L350 MSZST-L350 2016-10-04 10888628031531 Natrelle Inspira ST Resterilizable Sizers MSZST-L380 MSZST-L380 2016-10-05 10888628031548 Natrelle Inspira ST Resterilizable Sizers MSZST-L410 MSZST-L410 2016-10-05 10888628031555 Natrelle Inspira ST Resterilizable Sizers MSZST-L460 MSZST-L460 2016-10-05 10888628031562 Natrelle Inspira ST Resterilizable Sizers MSZST-L510 MSZST-L510 2016-10-05 10888628031579 Natrelle Inspira ST Resterilizable Sizers MSZST-L560 MSZST-L560 2016-10-05 10888628031586 Natrelle Inspira ST Resterilizable Sizers MSZST-L610 MSZST-L610 2017-03-20 10888628031593 Natrelle Inspira ST Resterilizable Sizers MSZST-LP125 MSZST-LP125 2016-10-05 10888628031609 Natrelle Inspira ST Resterilizable Sizers MSZST-LP145 MSZST-LP145 2016-10-05 10888628031616 Natrelle Inspira ST Resterilizable Sizers MSZST-LP165 MSZST-LP165 2016-10-05 10888628031623 Natrelle Inspira ST Resterilizable Sizers MSZST-LP190 MSZST-LP190 2016-10-05
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00380650500045 EX-PRESS Alcon Laboratories, Inc. KYF 2025-09-23 00892064002089 Ahmed ClearPath ST NEW WORLD MEDICAL, INCORPORATED KYF 2024-12-18 00892064002096 Ahmed ClearPath ST NEW WORLD MEDICAL, INCORPORATED KYF 2024-12-18 00853704002449 iStent Infinite GLAUKOS CORPORATION KYF 2022-10-19 00853704002470 iStent infinite GLAUKOS CORPORATION KYF 2022-10-05 00892064002188 Ahmed™ Glaucoma Valve NEW WORLD MEDICAL, INCORPORATED KYF 2020-08-12 00892064002348 Ahmed™ ClearPath NEW WORLD MEDICAL, INCORPORATED KYF 2019-01-23 00892064002355 Ahmed™ ClearPath NEW WORLD MEDICAL, INCORPORATED KYF 2019-01-23 10888628032439 XEN Glaucoma Treatment System Allergan, Inc. KYF 2018-01-30 00892064002126 Ahmed™ Glaucoma Valve NEW WORLD MEDICAL, INCORPORATED KYF 2017-09-08 00892064002119 Ahmed™ Glaucoma Valve NEW WORLD MEDICAL, INCORPORATED KYF 2016-11-16 09419196000014 Molteno MOLTENO OPHTHALMIC LIMITED KYF 2016-08-12 09419196000021 Molteno MOLTENO OPHTHALMIC LIMITED KYF 2016-08-12 09419196000038 Molteno MOLTENO OPHTHALMIC LIMITED KYF 2016-08-12 09419196000052 Molteno MOLTENO OPHTHALMIC LIMITED KYF 2016-08-12 09419196000069 Molteno MOLTENO OPHTHALMIC LIMITED KYF 2016-08-12 09419196000076 Molteno MOLTENO OPHTHALMIC LIMITED KYF 2016-08-12 09419196000083 Molteno MOLTENO OPHTHALMIC LIMITED KYF 2016-08-12 09419196000090 Molteno3 MOLTENO OPHTHALMIC LIMITED KYF 2016-08-12 09419196000106 Molteno3 MOLTENO OPHTHALMIC LIMITED KYF 2016-08-12 09419196000212 Molteno3 MOLTENO OPHTHALMIC LIMITED KYF 2016-08-12 09419196000229 Molteno3 MOLTENO OPHTHALMIC LIMITED KYF 2016-08-12 00380650704931 EX-PRESS® Alcon Laboratories, Inc. KYF 2015-10-24 00380650704948 EX-PRESS® Alcon Laboratories, Inc. KYF 2015-10-24 05050474512993 BAERVELDT GLAUCOMA IMPLANT (350) JOHNSON & JOHNSON SURGICAL VISION, INC. KYF 2015-09-15 05050474513006 BAERVELDT PARS PLANA GLAUCOMA IMPLANT JOHNSON & JOHNSON SURGICAL VISION, INC. KYF 2015-09-15 05050474513013 BAERVELDT GLAUCOMA IMPLANT (250) JOHNSON & JOHNSON SURGICAL VISION, INC. KYF 2015-09-15 00892064002140 Ahmed™ Glaucoma Valve NEW WORLD MEDICAL, INCORPORATED KYF 2015-03-24 00892064002270 Ahmed™ Glaucoma Valve NEW WORLD MEDICAL, INCORPORATED KYF 2015-03-24 00892064002133 Ahmed™ Glaucoma Valve NEW WORLD MEDICAL, INCORPORATED KYF 2015-03-24
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