Catalog Number

MD6PK

Brand Name

Magellan™

Version/Model Number

MD6PK

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

DXX

Product Code Name

System, Catheter Control, Steerable

Public Device Record Key

66ed4bf8-ddbb-408e-ae4e-32647ac4b69c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

00815671020086

Quantity per Package

6

Contains DI Package

10815671020083

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box