Catalog Number

-

Brand Name

Serene Medical

Version/Model Number

RFG-100.TC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K081729

Product Code

GXD

Product Code Name

Generator, Lesion, Radiofrequency

Public Device Record Key

a2868647-a6f8-426b-a723-b53cab5a9dd2

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

December 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-