Catalog Number

EEV-200

Brand Name

Endo-Ease Vista Retrograde

Version/Model Number

EEV-200

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

K080050,K080050

Product Code

FED

Product Code Name

Endoscopic Access Overtube, Gastroenterology-Urology

Public Device Record Key

8556b569-73f7-427a-be77-75cf1e29d80c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10867630000209

Quantity per Package

4

Contains DI Package

00867630000202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box