Catalog Number

-

Brand Name

Salinetrodeflex Bipolar RF Electrode

Version/Model Number

3 B 60 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

057b84c7-b5f8-4c5b-9066-eb8e6a81a24b

Public Version Date

April 24, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10851545007781

Quantity per Package

5

Contains DI Package

00851545007784

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box