Catalog Number

DBI25

Brand Name

Parkell®

Version/Model Number

DBI25

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 14, 2021

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

04e464e8-33d1-4c13-bb4b-ee3f5725a549

Public Version Date

August 26, 2021

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

-