Catalog Number

5513-001

Brand Name

XEN Glaucoma Treatment System

Version/Model Number

5513-001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

Yes

FDA Premarket Submission

K161457

Product Code

KYF

Product Code Name

Implant, Eye Valve

Public Device Record Key

a4ce3b83-8a89-486b-99ab-7c9a46de40c4

Public Version Date

August 24, 2021

Public Version Number

4

DI Record Publish Date

January 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-