Catalog Number

DORING-GR

Brand Name

Parkell®

Version/Model Number

DORING-GR

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)

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

c85945a9-a1f2-4f8e-a8c4-19ae3bd35e89

Public Version Date

February 17, 2020

Public Version Number

1

DI Record Publish Date

February 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-