Catalog Number

-

Brand Name

Magellan Complete Disposable Kit

Version/Model Number

TRU300-JPN

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)

-

FDA Premarket Submission

-

Product Code

-

Product Code Name

-

Public Device Record Key

fe276041-d28f-4c80-bd9b-c653c2933c9f

Public Version Date

July 23, 2020

Public Version Number

2

DI Record Publish Date

June 13, 2019

Package DI Number

M896TRU300JPN1

Quantity per Package

5

Contains DI Package

M896TRU300JPN0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box