Catalog Number

S-510

Brand Name

NeuroTherm™

Version/Model Number

CLASSIC

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

-

Product Code

GXI

Product Code Name

PROBE, RADIOFREQUENCY LESION

Public Device Record Key

d55c92ef-6675-4796-8a92-86c9824d1b2a

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 14, 2015

Package DI Number

15415067022285

Quantity per Package

10

Contains DI Package

05415067022288

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-