Catalog Number

PMK18200C

Brand Name

Halyard

Version/Model Number

99668

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 17, 2018

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K002389

Product Code

GXI

Product Code Name

PROBE, RADIOFREQUENCY LESION

Public Device Record Key

b6e377d5-031c-4597-a56d-9347340d4427

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

May 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-