Cobra PzF - NanoCoated Coronary Stent System - CELONOVA BIOSCIENCES, INC.

Duns Number:168593429

Device Description: NanoCoated Coronary Stent System

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

170-03-30018

Brand Name

Cobra PzF

Version/Model Number

170-03-30018

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"

Yes

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

P160014

Product Code Details

Product Code

MAF

Product Code Name

Stent, Coronary

Device Record Status

Public Device Record Key

cb560cd6-b860-4d4d-9943-d1f35a7c0fb7

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

October 20, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CELONOVA BIOSCIENCES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 46
3 A medical device with high risk that requires premarket approval 30