Catalog Number

-

Brand Name

Tri-Beam Nd:YAG Laser System

Version/Model Number

TRI-BEAM

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K122922,K122922

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

ca0c1f7f-3237-401c-9263-1154329e8023

Public Version Date

August 24, 2021

Public Version Number

4

DI Record Publish Date

October 31, 2016

Package DI Number

8800020102034

Quantity per Package

1

Contains DI Package

08800020102010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Wooden crate