Catalog Number

PMK18100

Brand Name

Halyard

Version/Model Number

98660

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

-

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

GXD

Product Code Name

GENERATOR, LESION, RADIOFREQUENCY

Public Device Record Key

eed7a1a3-895e-463d-8764-cf3a2c666d27

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

May 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-