Catalog Number

095449

Brand Name

LEONI™

Version/Model Number

LFS-365-SB

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

7b7eaf86-33b7-4c06-9dbf-41b579358d19

Public Version Date

June 09, 2021

Public Version Number

1

DI Record Publish Date

June 01, 2021

Package DI Number

02816901022694

Quantity per Package

2

Contains DI Package

01816901022695

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-