Catalog Number

-

Brand Name

Edge ONE

Version/Model Number

Edge ONE

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

K162169,K162169

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

0d8d3692-1584-4430-ae4e-1536bb736e39

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

November 18, 2016

Package DI Number

8800020110039

Quantity per Package

1

Contains DI Package

08800020110015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Wooden Crate