Catalog Number

-

Brand Name

Max360® Three Mirror Universal Gonio Laser Lens w/ Flange 20mm O.D.

Version/Model Number

OG3MSFA-IR

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"

-

For Single-Use

-

Prescription Use (Rx)

-

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

dba40dc7-1567-4a95-abb8-8f0b4fe934bf

Public Version Date

March 17, 2021

Public Version Number

2

DI Record Publish Date

June 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-