Catalog Number

53671

Brand Name

Gonio Ready 200 for f=200mm

Version/Model Number

53671

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)

-

FDA Premarket Submission

-

Product Code

HKS

Product Code Name

Prism, Gonioscopic

Public Device Record Key

7027f553-3cdf-4a9b-9ef5-3456247212fb

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

August 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-