Catalog Number

SIK-17-150-4

Brand Name

Halyard

Version/Model Number

99714

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K053082

Product Code

GXI

Product Code Name

PROBE, RADIOFREQUENCY LESION

Public Device Record Key

7124254a-21d6-4cdf-adf6-c5dbbf89b9dd

Public Version Date

November 16, 2018

Public Version Number

4

DI Record Publish Date

September 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-