Catalog Number

-

Brand Name

NITREX™

Version/Model Number

N180603

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

K040345,K040345

Product Code

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

28e079cf-ce8a-43d9-9fd8-510c6db6b825

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

August 16, 2020

Package DI Number

20763000185385

Quantity per Package

3

Contains DI Package

00763000185381

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK