Catalog Number

-

Brand Name

VA-HP

Version/Model Number

VA-HP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 25, 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

K071447,K071447

Product Code

ELC

Product Code Name

Scaler, ultrasonic

Public Device Record Key

f5a4bf36-e0b6-4f71-9c72-edd582d04d5e

Public Version Date

January 12, 2022

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-