Catalog Number

PMA-BP

Brand Name

AVANOS

Version/Model Number

PMA-BP

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

K002389,K002389

Product Code

GXI

Product Code Name

Probe, radiofrequency lesion

Public Device Record Key

ce8766c4-af0f-4078-8dca-27bc2fe9b5c5

Public Version Date

August 18, 2020

Public Version Number

1

DI Record Publish Date

August 10, 2020

Package DI Number

10193493985958

Quantity per Package

20

Contains DI Package

00193493985951

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS