Catalog Number

-

Brand Name

LCCS

Version/Model Number

RE25100-R-LC

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

K152642,K152642

Product Code

GXI

Product Code Name

Probe, Radiofrequency Lesion

Public Device Record Key

4bd6d140-5ed4-4aea-86ff-a523eb16a87a

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

July 24, 2021

Package DI Number

64895233605324

Quantity per Package

100

Contains DI Package

04895233605322

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton