Catalog Number

LX1813063005F

Brand Name

LUTONIX® Drug Coated Balloon

Version/Model Number

LX1813063005F

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ONU

Product Code Name

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Public Device Record Key

13ea49a3-1511-4e64-a76d-8a89806906b1

Public Version Date

February 07, 2020

Public Version Number

1

DI Record Publish Date

January 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-