Catalog Number

620414

Brand Name

Denticator

Version/Model Number

620414

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

JET

Product Code Name

PICK, MASSAGING

Public Device Record Key

17a80a56-aef0-4ceb-b04a-820975928516

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 16, 2022

Package DI Number

10302736204149

Quantity per Package

144

Contains DI Package

00302736204142

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Package