Catalog Number

-

Brand Name

Eswallow

Version/Model Number

ESW-9960

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

-

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

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

e56a9ca6-6d5c-4229-9254-6304a0b79057

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 13, 2016

Package DI Number

80092237618284

Quantity per Package

20

Contains DI Package

00092237618288

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA