Catalog Number

-

Brand Name

GT8 Heavy Ball Electrode (2.38mm)

Version/Model Number

GT8

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

K020080

Product Code

EKZ

Product Code Name

Unit, Electrosurgical, And Accessories, Dental

Public Device Record Key

5149fdf4-ba70-4cfc-8f7f-325e4e892ab9

Public Version Date

March 06, 2020

Public Version Number

1

DI Record Publish Date

February 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-