Rexall - Rexall Soniclean Pro 5 Toothbrush - DOLGENCORP, LLC

Duns Number:068331990

Device Description: Rexall Soniclean Pro 5 Toothbrush

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More Product Details

Catalog Number

-

Brand Name

Rexall

Version/Model Number

25446001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 24, 2030

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

be92c310-57f9-493d-81d9-1b00119377ac

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

June 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DOLGENCORP, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 9
U Unclassified 1