Catalog Number

-

Brand Name

1.5 mm OTW B-Laser™ catheter

Version/Model Number

EXM-4001-0000

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)

-

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

ded3883c-5a30-487c-8490-b4fb7c927fa2

Public Version Date

April 01, 2019

Public Version Number

1

DI Record Publish Date

March 22, 2019

Package DI Number

17290017590001

Quantity per Package

11

Contains DI Package

07290017590004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton Box