Catalog Number

SMK-S1002-22

Brand Name

NeuroTherm™

Version/Model Number

SMK

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

K042375,K042375

Product Code

GXI

Product Code Name

PROBE, RADIOFREQUENCY LESION

Public Device Record Key

a48f1669-d405-43eb-8292-d568126a554f

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

March 23, 2016

Package DI Number

15415067021790

Quantity per Package

10

Contains DI Package

05415067021793

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-