Catalog Number

-

Brand Name

PK BUTTON (BOX OF 5)

Version/Model Number

786500

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

K093181,K093181

Product Code

FAS

Product Code Name

ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Public Device Record Key

a9ac69fa-0ce9-468a-b347-032a28bba0bb

Public Version Date

March 14, 2022

Public Version Number

4

DI Record Publish Date

October 04, 2016

Package DI Number

00821925011519

Quantity per Package

5

Contains DI Package

00821925039520

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-