Toothbrushes - Toothbrushes, Soft Nylon Bristles, 46 Tufts, Teal - DYNAREX CORPORATION

Duns Number:008124539

Device Description: Toothbrushes, Soft Nylon Bristles, 46 Tufts, Teal

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More Product Details

Catalog Number

-

Brand Name

Toothbrushes

Version/Model Number

4862

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"

Yes

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

EFW

Product Code Name

Toothbrush, Manual

Device Record Status

Public Device Record Key

89b7d8ae-037b-4f33-b36f-e1d6b2d821c7

Public Version Date

September 09, 2021

Public Version Number

1

DI Record Publish Date

September 01, 2021

Additional Identifiers

Package DI Number

00616784486239

Quantity per Package

10

Contains DI Package

00616784486222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2