Catalog Number

2008 S

Brand Name

SONICflex 2008 S

Version/Model Number

1.007.0541

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K080089

Product Code

ELC

Product Code Name

Scaler, ultrasonic

Public Device Record Key

713fc5f7-fa42-4a0b-a98a-d29f0625dfe3

Public Version Date

November 08, 2021

Public Version Number

5

DI Record Publish Date

September 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-