Catalog Number

712

Brand Name

Ritch Trabeculoplasty Laser Lens

Version/Model Number

ORTA

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

K862512,K862512

Product Code

HKS

Product Code Name

Prism, Gonioscopic

Public Device Record Key

c34bda3f-bd2d-4385-bb47-ea4cd3142f46

Public Version Date

March 17, 2021

Public Version Number

3

DI Record Publish Date

June 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-