Catalog Number

RETeval Complete USA

Brand Name

RETeval™

Version/Model Number

RETeval Complete USA

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

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

K142567

Product Code

GWE

Product Code Name

Stimulator, Photic, Evoked Response

Public Device Record Key

e3721e11-601d-4afd-9c17-369001e5c07b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-