Catalog Number

401752

Brand Name

Orsiro

Version/Model Number

4.0/18/140

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

NIQ

Product Code Name

Coronary drug-eluting stent

Public Device Record Key

22258305-95b9-45c3-a44e-1d1d25cfc2a2

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

February 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-