Catalog Number

UI30PPSB

Brand Name

Hu-Friedy

Version/Model Number

UI30PPSB

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K012060

Product Code

ELC

Product Code Name

Scaler, ultrasonic

Public Device Record Key

3ffd2b89-eb5f-4849-84bf-7cc39ee6cb6a

Public Version Date

December 28, 2020

Public Version Number

1

DI Record Publish Date

December 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-