Catalog Number

FFS002-01

Brand Name

FullFire® Select Diffusing Tip Laser Probe

Version/Model Number

20624-00

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 10, 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

K143457

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

4d104ffd-9307-4a8a-9c0c-fdacae5073d1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-