Catalog Number

170-03-30008

Brand Name

Cobra PzF

Version/Model Number

170-03-30008

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"

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

MAF

Product Code Name

Stent, Coronary

Public Device Record Key

90beb09c-6fd9-403f-b253-506df34071d4

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

October 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-