Catalog Number

RLV RFG01

Brand Name

Relievant

Version/Model Number

FG 0052

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171143

Product Code

GXD

Product Code Name

Generator, Lesion, Radiofrequency

Public Device Record Key

b11177d3-2599-40e8-b14d-3d227dd2ce00

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

April 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-