Catalog Number

101030

Brand Name

Endovascular Laser Vein System (ELVeS®) Kit

Version/Model Number

ELVeS® Radial® Kit 6Fx11cm

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

-

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

b70c60ed-3b8f-4166-9878-3f374df379b5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 31, 2017

Package DI Number

04049089200266

Quantity per Package

5

Contains DI Package

04049089100269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box