Catalog Number

PMC22-54-5CS

Brand Name

AVANOS

Version/Model Number

PMC22-54-5CS

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

dc1408cb-47ca-4af1-adf9-e29cf88116d3

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

July 25, 2020

Package DI Number

20193493986273

Quantity per Package

20

Contains DI Package

10193493986276

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS