Catalog Number

C408643

Brand Name

Dragonfly™

Version/Model Number

Duo Kit

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

-

Product Code

ORD

Product Code Name

Optical coherence tomography, intravascular catheter

Public Device Record Key

5cd9f041-f75d-4651-ae1b-0d18542fa709

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 20, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-