Catalog Number

DLH30TRI-PF

Brand Name

TurboVue™

Version/Model Number

DLH30TRI-PF

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 11, 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

0ab2f610-166d-4539-91c8-bbb57347d405

Public Version Date

November 24, 2020

Public Version Number

2

DI Record Publish Date

September 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-