XEN Glaucoma Treatment System 5513-001

GUDID 10888628032439

XEN Sterile Injector US

Allergan, Inc.

Glaucoma shunt
Primary Device ID10888628032439
NIH Device Record Keya4ce3b83-8a89-486b-99ab-7c9a46de40c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameXEN Glaucoma Treatment System
Version Model Number5513-001
Catalog Number5513-001
Company DUNS144796497
Company NameAllergan, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-624-4261
EmailProductSupport@allergan.com
Phone800-624-4261
EmailProductSupport@allergan.com
Phone800-624-4261
EmailProductSupport@allergan.com
Phone800-624-4261
EmailProductSupport@allergan.com
Phone800-624-4261
EmailProductSupport@allergan.com
Phone800-624-4261
EmailProductSupport@allergan.com
Phone800-624-4261
EmailProductSupport@allergan.com
Phone800-624-4261
EmailProductSupport@allergan.com
Phone800-624-4261
EmailProductSupport@allergan.com
Phone800-624-4261
EmailProductSupport@allergan.com
Phone800-624-4261
EmailProductSupport@allergan.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110888628032439 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KYFImplant, Eye Valve

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-30

Devices Manufactured by Allergan, Inc.

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