Catalog Number

-

Brand Name

Integrity

Version/Model Number

INT22514UX

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

-

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

-

FDA Premarket Submission

P030009,P030009,P030009

Product Code

MAF

Product Code Name

STENT, CORONARY

Public Device Record Key

f6a910a4-f2e9-4574-86cf-6691a2c4cfb8

Public Version Date

January 18, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-