Catalog Number

-

Brand Name

SalinetrodeFlex Bipolar RF Electrode

Version/Model Number

4B 40 S

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FAS

Product Code Name

Electrode, Electrosurgical, Active, Urological

Public Device Record Key

d2eb250e-cb1b-4c2b-bf21-028bdbe45363

Public Version Date

April 23, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10851545007408

Quantity per Package

5

Contains DI Package

00851545007401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box