Catalog Number

LAS-100

Brand Name

Philips Laser System

Version/Model Number

LAS-100

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

-

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

P910001

Product Code

LPC

Product Code Name

Device, Angioplasty, Laser, Coronary

Public Device Record Key

92448e08-4d46-48cf-8394-6f03df0a1196

Public Version Date

October 26, 2021

Public Version Number

2

DI Record Publish Date

September 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-