Catalog Number

098751

Brand Name

NA

Version/Model Number

LFS-600-SF

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 07, 2021

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

153a699a-3560-4e3a-aed5-a0ff57df15e7

Public Version Date

May 07, 2021

Public Version Number

2

DI Record Publish Date

April 01, 2021

Package DI Number

02816901022274

Quantity per Package

25

Contains DI Package

01816901022275

Package Discontinue Date

May 07, 2021

Package Status

Not in Commercial Distribution

Package Type

-