Catalog Number

M220522N

Brand Name

CoolLipoTM

Version/Model Number

CL 500 R

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

-

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

K050738,K050738,K050738

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

b223f01d-7066-474d-be8d-e1533ab40d47

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 29, 2016

Package DI Number

04059497000587

Quantity per Package

2

Contains DI Package

04059497000341

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-