Catalog Number

PMF22-100-5

Brand Name

Halyard

Version/Model Number

98645

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

-

Product Code

GXI

Product Code Name

PROBE, RADIOFREQUENCY LESION

Public Device Record Key

677c7cbd-35b9-4c0b-b57a-32e989715a2f

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

May 17, 2016

Package DI Number

30680651986451

Quantity per Package

10

Contains DI Package

10680651986457

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS