Catalog Number

DPL25

Brand Name

Parkell®

Version/Model Number

DPL25

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 13, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ELC

Product Code Name

Scaler, Ultrasonic

Public Device Record Key

aec168a7-37ef-4ff9-9fad-b217e516da45

Public Version Date

November 24, 2020

Public Version Number

2

DI Record Publish Date

November 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-