Catalog Number

095442

Brand Name

FiberTech®

Version/Model Number

LFR-550

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K050738,K050738,K050738

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

e8fed5cd-bf49-452c-8572-7c11a93a323f

Public Version Date

November 15, 2018

Public Version Number

4

DI Record Publish Date

September 28, 2016

Package DI Number

02816901020690

Quantity per Package

2

Contains DI Package

01816901020691

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-