Catalog Number

UI30PPTC

Brand Name

Hu-Friedy

Version/Model Number

UI30PPTC

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

5aec3dcb-eb19-428e-8405-65b7d31b8740

Public Version Date

December 23, 2019

Public Version Number

1

DI Record Publish Date

December 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-