Catalog Number

LS9005-05 Pouch

Brand Name

LightScalpel

Version/Model Number

LS9005-05

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

K081612,K121471,K081612,K121471

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

a5d67930-b1c9-4404-b27b-1be2f97de5bb

Public Version Date

August 02, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10851842007286

Quantity per Package

1

Contains DI Package

00851842007289

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box