Catalog Number

AB35SX060080080

Brand Name

Stellarex™

Version/Model Number

AB35SX060080080-A

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

P160049

Product Code

ONU

Product Code Name

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Public Device Record Key

bf83bdbc-035f-4b3e-86e6-d9be52f54cd0

Public Version Date

January 21, 2022

Public Version Number

1

DI Record Publish Date

January 13, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-