Solimo - Power Toothbrush, Kids Polka Dots - AMAZON.COM SERVICES LLC

Duns Number:128990418

Device Description: Power Toothbrush, Kids Polka Dots

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More Product Details

Catalog Number

-

Brand Name

Solimo

Version/Model Number

BLB

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)

-

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

8016984d-e758-4ca2-8e85-6156e684d477

Public Version Date

August 27, 2020

Public Version Number

1

DI Record Publish Date

August 19, 2020

Additional Identifiers

Package DI Number

10842379159203

Quantity per Package

18

Contains DI Package

00842379159206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"AMAZON.COM SERVICES LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 8