Catalog Number

55912

Brand Name

PI01-R

Version/Model Number

PI01-R

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K844250

Product Code

ELC

Product Code Name

Scaler, ultrasonic

Public Device Record Key

83b6905a-3eb0-40a5-bf29-c1fde9a1ad54

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-