Catalog Number

PMP-21-100

Brand Name

AVANOS

Version/Model Number

PMP-21-100

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

K002389,K002389,K002389

Product Code

GXI

Product Code Name

Probe, radiofrequency lesion

Public Device Record Key

3c53e56b-c50a-42f2-9587-25530a6aa35d

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

August 25, 2020

Package DI Number

10193493986894

Quantity per Package

10

Contains DI Package

00193493986897

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS