Electric Toothbrsuh - Power toothbrush-Gunmetal-ECOMM - Access Dental Lab, LLC

Duns Number:054012763

Device Description: Power toothbrush-Gunmetal-ECOMM

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More Product Details

Catalog Number

-

Brand Name

Electric Toothbrsuh

Version/Model Number

100-0359

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

510dd9e1-217a-4b93-b3a6-81f58f3d4785

Public Version Date

April 15, 2021

Public Version Number

3

DI Record Publish Date

August 14, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACCESS DENTAL LAB, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 8