Catalog Number

-

Brand Name

QEVO ECU

Version/Model Number

7213

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170667

Product Code

GWG

Product Code Name

Endoscope, Neurological

Public Device Record Key

4e4490d1-6b31-4c13-ae7b-c8065023fea1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-