Catalog Number

6552

Brand Name

Toothette Oral Care

Version/Model Number

6552

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Public Device Record Key

b675344b-b976-4265-b768-e40365f1b522

Public Version Date

July 07, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

50618029821152

Quantity per Package

25

Contains DI Package

00618029821157

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case