Catalog Number

-

Brand Name

ElectroTips

Version/Model Number

ET-104

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

Yes

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

9f2cb3c6-43c4-4f49-8522-d25b5f9d7e91

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

May 13, 2016

Package DI Number

20609960000163

Quantity per Package

38

Contains DI Package

10609960000166

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case