Catalog Number

-

Brand Name

Panasonic

Version/Model Number

EW1213A351

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EFS

Product Code Name

Unit, Oral Irrigation

Public Device Record Key

8b4baf48-844d-4c30-8fe1-fdde40ed04f3

Public Version Date

June 30, 2020

Public Version Number

1

DI Record Publish Date

June 22, 2020

Package DI Number

10851439007040

Quantity per Package

5

Contains DI Package

00851439007043

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-