Cordis S.M.A.R.T. Vascular Stent System - CORDIS CORPORATION

Duns Number:806136177

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More Product Details

Catalog Number

C06150ML

Brand Name

Cordis S.M.A.R.T. Vascular Stent System

Version/Model Number

C06150ML

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

NIP

Product Code Name

STENT, SUPERFICIAL FEMORAL ARTERY

Device Record Status

Public Device Record Key

f27562d5-9825-4ce1-a40a-9c93475d7ebf

Public Version Date

August 05, 2022

Public Version Number

8

DI Record Publish Date

September 19, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CORDIS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2567
3 A medical device with high risk that requires premarket approval 204