Catalog Number

8065990817

Brand Name

WAVENET

Version/Model Number

8065990817

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2014

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

P020050,P030008

Product Code

LZS

Product Code Name

Excimer Laser System

Public Device Record Key

a50088a6-e8c4-46ea-9e8d-811f5f7a552f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-