Catalog Number

-

Brand Name

Signature Series

Version/Model Number

M0065051610

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

7930e07c-432d-40ca-aecb-6cdb27e65b33

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

08714729802723

Quantity per Package

10

Contains DI Package

08714729890027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-