Catalog Number

-

Brand Name

Equaline

Version/Model Number

ULE

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JEQ

Product Code Name

Toothbrush, Powered

Public Device Record Key

721109aa-dbcf-4f01-908c-85b271870f18

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

June 25, 2020

Package DI Number

10041163498614

Quantity per Package

36

Contains DI Package

00041163498617

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case