Philips Sonicare - Software, Sonicare Power Tooth brush, Web - PHILIPS ORAL HEALTHCARE, LLC

Duns Number:608729869

Device Description: Software, Sonicare Power Tooth brush, Web download App Android

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More Product Details

Catalog Number

-

Brand Name

Philips Sonicare

Version/Model Number

HX9999/99

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

9c820b58-9a6c-48f0-b69b-af7da524d5dc

Public Version Date

April 01, 2021

Public Version Number

1

DI Record Publish Date

March 24, 2021

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