Catalog Number

6571

Brand Name

Toothette Oral Care

Version/Model Number

6571

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 21, 2018

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

6bd6ec38-a5ff-45cc-aa25-663e13555f70

Public Version Date

July 26, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

50618029821053

Quantity per Package

100

Contains DI Package

00618029821058

Package Discontinue Date

March 21, 2018

Package Status

Not in Commercial Distribution

Package Type

case