Catalog Number

RFA201010SSL

Brand Name

Medline Industries, Inc.

Version/Model Number

RFA201010SSL

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

K032196,K032196

Product Code

GXI

Product Code Name

Probe, radiofrequency lesion

Public Device Record Key

7b113beb-e446-4910-bf06-6a064ae5e473

Public Version Date

August 12, 2022

Public Version Number

1

DI Record Publish Date

August 04, 2022

Package DI Number

40195327047031

Quantity per Package

25

Contains DI Package

10195327047030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE