Philips Sonicare - Power Tooth Brush Starter Kit - PHILIPS ORAL HEALTHCARE, LLC

Duns Number:608729869

Device Description: Power Tooth Brush Starter Kit

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More Product Details

Catalog Number

-

Brand Name

Philips Sonicare

Version/Model Number

HX9911/91

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

JEQ

Product Code Name

Toothbrush, Powered

Device Record Status

Public Device Record Key

fcdb02e8-de49-4d60-8ee1-b828ce5e8cd7

Public Version Date

July 06, 2022

Public Version Number

1

DI Record Publish Date

June 28, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHILIPS ORAL HEALTHCARE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 600