Catalog Number

-

Brand Name

NA

Version/Model Number

DSE0005

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

K061639,K061639

Product Code

GWE

Product Code Name

STIMULATOR, PHOTIC, EVOKED RESPONSE

Public Device Record Key

28b2c6e9-8906-4d54-a4fb-b6460eada859

Public Version Date

February 24, 2021

Public Version Number

4

DI Record Publish Date

April 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-