Catalog Number

-

Brand Name

GentleMax

Version/Model Number

9914-00-0400

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 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

K140732

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

23bc7f8b-8dbe-47bd-a183-92174db5e064

Public Version Date

October 12, 2022

Public Version Number

7

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-