Catalog Number

-

Brand Name

3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton(plus)

Version/Model Number

DRI OCT Triton(plus)

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HKI

Product Code Name

Camera, ophthalmic, ac-powered

Public Device Record Key

e28bf35f-6dd6-49fd-b3af-c24a8c1995e8

Public Version Date

August 27, 2018

Public Version Number

4

DI Record Publish Date

February 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-