Catalog Number

RL MDGPD12C996

Brand Name

Applied Medical Laser

Version/Model Number

Skin Cooling

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 05, 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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

940e9d40-0bb8-461b-ac5c-7e1576b799a1

Public Version Date

August 06, 2020

Public Version Number

2

DI Record Publish Date

April 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-