Catalog Number

-

Brand Name

Brasseler USA

Version/Model Number

5019435U0

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)

-

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

e2cfb05b-a77d-4abe-9d67-3919d40aace0

Public Version Date

February 21, 2019

Public Version Number

3

DI Record Publish Date

September 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-