Catalog Number

-

Brand Name

EFFDNT PLUS MNT 126CT TAB 6

Version/Model Number

10814832017054

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

-

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

EFT

Product Code Name

Cleanser, Denture, Over The Counter

Public Device Record Key

6efb9fff-8131-4177-b602-e6f00bbe9f12

Public Version Date

October 06, 2022

Public Version Number

1

DI Record Publish Date

September 28, 2022

Package DI Number

10814832017054

Quantity per Package

126

Contains DI Package

00814832015916

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Multiple