Catalog Number

-

Brand Name

Cool-tip

Version/Model Number

CTRF 100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 13, 2020

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

-

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

K973297

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

5df909e2-bdf8-479f-9270-80d7431555c2

Public Version Date

October 17, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-