Catalog Number

-

Brand Name

UTAS

Version/Model Number

UTAS System Type-99

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GWE

Product Code Name

Stimulator, Photic, Evoked Response

Public Device Record Key

5eddcdd8-6b6b-487b-b854-e28886a2eb18

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-