Catalog Number

CRKA-17-100-4

Brand Name

AVANOS

Version/Model Number

CRKA-17-100-4

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

-

Product Code

GXI

Product Code Name

Probe, radiofrequency lesion

Public Device Record Key

a2b0c3f7-5ea8-453e-9100-214a6a20f21d

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

March 11, 2021

Package DI Number

10193493479068

Quantity per Package

12

Contains DI Package

00193493479061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS