Catalog Number

PMA-AC-100675

Brand Name

AVANOS*

Version/Model Number

PMA-AC-100675

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"

Yes

For Single-Use

-

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

K002389,K002389

Product Code

GXI

Product Code Name

Probe, radiofrequency lesion

Public Device Record Key

e985d559-5e78-4c1a-9f7f-db7f7068ee2c

Public Version Date

March 21, 2022

Public Version Number

1

DI Record Publish Date

March 12, 2022

Package DI Number

10193493985927

Quantity per Package

15

Contains DI Package

00193493985920

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS