Catalog Number

098890

Brand Name

LEONI™

Version/Model Number

LFS-400-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

d3e00cf3-4c25-4c58-af4a-a6e241c8569f

Public Version Date

June 09, 2021

Public Version Number

1

DI Record Publish Date

June 01, 2021

Package DI Number

01816901022800

Quantity per Package

5

Contains DI Package

00816901022801

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-