Catalog Number

622514

Brand Name

Denticator

Version/Model Number

622514

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"

-

For Single-Use

Yes

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

d2601dda-0daa-4592-a989-7bfd47709a3c

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 16, 2022

Package DI Number

10302736225144

Quantity per Package

144

Contains DI Package

00302736225147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Package