XEN Glaucoma Treatment System

Basic Information

• Brand Name: XEN Glaucoma Treatment System
• Primary DI: 10888628032439
• Version / Model: 5513-001
• Catalog Number: 5513-001
• Company Name: Allergan, Inc.
• Labeler DUNS: 144796497
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-30
• Public Version: 4
• Public Version Date: 2021-08-24
• Public Version Status: Update
• Public Device Record Key: a4ce3b83-8a89-486b-99ab-7c9a46de40c4

Device Description

XEN Sterile Injector US

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYF	Implant, Eye Valve	Ophthalmic	886.3920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61127	Glaucoma shunt	A non-bioabsorbable, implantable ocular device 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 uncontrolled glaucoma. It consists of a tube which is introduced into the aqueous body (typically via limbal entry) and a distal episcleral plate intended to support a reservoir of aqueous humour; the shunt does not contain a valve.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888628032439	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K161457	000