Catalog Number

RO-300

Brand Name

Magellan® Complete Disposable kit

Version/Model Number

RO-300

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 04, 2019

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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

b80dc664-e770-4fac-842c-d1fd388b2730

Public Version Date

July 23, 2020

Public Version Number

5

DI Record Publish Date

November 06, 2017

Package DI Number

M896RO3001

Quantity per Package

5

Contains DI Package

M896RO3000

Package Discontinue Date

November 04, 2019

Package Status

Not in Commercial Distribution

Package Type

-