Catalog Number

-

Brand Name

HEBuddy

Version/Model Number

BLB

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)

-

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

0538b7b5-cf13-4bb4-892a-6ec42e1d9bc1

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Package DI Number

40041220863172

Quantity per Package

3

Contains DI Package

00041220863174

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner