Catalog Number

03-5201

Brand Name

Flexible Video Esophagoscope (NTSC)

Version/Model Number

TNE-5000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 26, 2018

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"

Yes

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

-

Product Code

EOX

Product Code Name

Esophagoscope (Flexible Or Rigid)

Public Device Record Key

0cfe24d9-3017-4be2-b8b2-6871adce2e0d

Public Version Date

July 02, 2019

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-