Catalog Number

095450

Brand Name

NA

Version/Model Number

LFS-550-SB

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

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

K050738,K050738,K050738

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

08c44bc9-14bd-47e0-893e-226984772a53

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

August 22, 2019

Package DI Number

01816901021933

Quantity per Package

5

Contains DI Package

00816901021934

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-