Catalog Number

03-5101

Brand Name

EndoSheath Technology

Version/Model Number

TV-2.1

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"

Yes

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

K072088,K072088

Product Code

EOX

Product Code Name

Esophagoscope (Flexible Or Rigid)

Public Device Record Key

ce365a08-efdd-4365-b903-5144324ba7d7

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

20874485002996

Quantity per Package

10

Contains DI Package

00874485002985

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-