Catalog Number

-

Brand Name

ProCare Dent 10 MA

Version/Model Number

4029577154967

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

FLG

Product Code Name

Cleaner, Ultrasonic, Medical Instrument

Public Device Record Key

dc1c9497-17f9-4016-ba7b-9c7ac460219f

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 02, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-