Catalog Number

FFS422-01

Brand Name

FullFire® Select Diffusing Tip Laser Probe

Version/Model Number

20624-4

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 25, 2017

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

Yes

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

cfadde30-2489-4ff2-83b8-45fb9e888e26

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-