Catalog Number

-

Brand Name

Signature Series

Version/Model Number

M0068804420

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

K962593,K962593

Product Code

FAS

Product Code Name

Electrode, Electrosurgical, Active, Urological

Public Device Record Key

d03f88db-9551-4a76-80af-00409ce6bf6f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

08714729258353

Quantity per Package

10

Contains DI Package

08714729520610

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-