Catalog Number

EXM-2001-1100

Brand Name

Auryon Laser System 100-120 Vac

Version/Model Number

EXM-2001-1100

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

K181642,K181642

Product Code

MCW

Product Code Name

Catheter, Peripheral, Atherectomy

Public Device Record Key

e324682e-3c0b-4eaf-a88d-016680281f58

Public Version Date

June 04, 2020

Public Version Number

2

DI Record Publish Date

May 20, 2020

Package DI Number

17290017590131

Quantity per Package

1

Contains DI Package

07290017590110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Crate