Catalog Number

-

Brand Name

LCCS

Version/Model Number

S-1010-22-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"

Yes

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

K112231,K112231,K112231

Product Code

GXI

Product Code Name

Probe, Radiofrequency Lesion

Public Device Record Key

00d998c3-4e65-4527-9b3c-326361e86831

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 01, 2020

Package DI Number

64895233602132

Quantity per Package

40

Contains DI Package

14895233602137

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton