Catalog Number

-

Brand Name

Remanufactured, Icon Laser System

Version/Model Number

R105-2500-000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 02, 2022

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

-

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

000fd0b6-ae70-42f6-8a10-1d3ad3d0c445

Public Version Date

August 09, 2022

Public Version Number

3

DI Record Publish Date

July 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-