Catalog Number

-

Brand Name

Navilyst

Version/Model Number

96000218

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"

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)

Yes

FDA Premarket Submission

-

Product Code

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

96190ca7-c159-4343-a837-87b99a2cf4af

Public Version Date

April 01, 2019

Public Version Number

2

DI Record Publish Date

January 11, 2019

Package DI Number

H965960002181

Quantity per Package

5

Contains DI Package

H965960002180

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box