Catalog Number

-

Brand Name

Navilyst

Version/Model Number

97000307

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

e2852a5b-1fd6-4701-a182-1505e1064cb9

Public Version Date

May 16, 2022

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

H965970003071

Quantity per Package

10

Contains DI Package

H965970003070

Package Discontinue Date

May 13, 2022

Package Status

Not in Commercial Distribution

Package Type

BOX