Catalog Number

-

Brand Name

EsoFLIP

Version/Model Number

ES-310

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PIE

Product Code Name

Esophageal Dilator With Balloon And Electrode Sensors

Public Device Record Key

3476681c-f63b-4c38-9144-ca7fa8e1d127

Public Version Date

April 29, 2020

Public Version Number

2

DI Record Publish Date

April 16, 2020

Package DI Number

05391530810159

Quantity per Package

5

Contains DI Package

05391530810135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box