Catalog Number

SL-C1005-20

Brand Name

NeuroTherm™

Version/Model Number

SL

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

57ad228d-4443-4d83-952e-66a2cc88eca9

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

July 31, 2015

Package DI Number

15415067021714

Quantity per Package

10

Contains DI Package

05415067021717

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-