Catalog Number

F00022

Brand Name

Hydrus® Microstent

Version/Model Number

F00022

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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"

-

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)

-

FDA Premarket Submission

P170034,P170034,P170034,P170034,P170034,P170034,P170034,P170034,P170034

Product Code

OGO

Product Code Name

Intraocular Pressure Lowering Implant

Public Device Record Key

8b5808c8-2c9a-47fb-b539-d2333aac305b

Public Version Date

August 24, 2021

Public Version Number

4

DI Record Publish Date

August 15, 2018

Package DI Number

20867487000138

Quantity per Package

6

Contains DI Package

10867487000131

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton