Catalog Number

-

Brand Name

Diopsys®

Version/Model Number

6020-0001-01

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101763

Product Code

GWE

Product Code Name

Stimulator, Photic, Evoked Response

Public Device Record Key

7f924d2e-130d-4a69-80d8-1af3f6bffa83

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-