Catalog Number

-

Brand Name

Balance

Version/Model Number

0628

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

EFW

Product Code Name

Toothbrush, Manual

Public Device Record Key

1dbda730-1a22-4476-87ba-7f8987f1ac3c

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

June 08, 2018

Package DI Number

10875011006283

Quantity per Package

100

Contains DI Package

00875011006286

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton