XEN Glaucoma Treatment System 5513-001

GUDID 10888628032439

XEN Sterile Injector US

Allergan, Inc.

Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt

• Primary Device ID: 10888628032439
• NIH Device Record Key: a4ce3b83-8a89-486b-99ab-7c9a46de40c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XEN Glaucoma Treatment System
• Version Model Number: 5513-001
• Catalog Number: 5513-001
• Company DUNS: 144796497
• Company Name: Allergan, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-624-4261
• Email: ProductSupport@allergan.com
• Phone: 800-624-4261
• Email: ProductSupport@allergan.com
• Phone: 800-624-4261
• Email: ProductSupport@allergan.com
• Phone: 800-624-4261
• Email: ProductSupport@allergan.com
• Phone: 800-624-4261
• Email: ProductSupport@allergan.com
• Phone: 800-624-4261
• Email: ProductSupport@allergan.com
• Phone: 800-624-4261
• Email: ProductSupport@allergan.com
• Phone: 800-624-4261
• Email: ProductSupport@allergan.com
• Phone: 800-624-4261
• Email: ProductSupport@allergan.com
• Phone: 800-624-4261
• Email: ProductSupport@allergan.com
• Phone: 800-624-4261
• Email: ProductSupport@allergan.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888628032439 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161457

FDA Product Code

• KYF: Implant, Eye Valve

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: 2018-07-06
• Device Publish Date: 2018-01-30

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