Catalog Number

RF-DGP-L

Brand Name

NeuroTherm™

Version/Model Number

RF-DGP-L

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

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

f4268b73-7bc2-4386-88d3-3f12e4b470ed

Public Version Date

June 05, 2020

Public Version Number

3

DI Record Publish Date

July 31, 2015

Package DI Number

15415067023619

Quantity per Package

10

Contains DI Package

05415067023612

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-