Catalog Number

-

Brand Name

BioSonic

Version/Model Number

60014456

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130137,K130137

Product Code

ELC

Product Code Name

Scaler, Ultrasonic

Public Device Record Key

abdca06c-266a-4b47-926d-75f730399464

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-