Catalog Number

-

Brand Name

Eswallow

Version/Model Number

ESW-9010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2017

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

e01115cd-5537-40ad-8113-749f8a4b8937

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 18, 2016

Package DI Number

80092237618246

Quantity per Package

16

Contains DI Package

00092237618240

Package Discontinue Date

June 30, 2017

Package Status

Not in Commercial Distribution

Package Type

CA