Catalog Number

-

Brand Name

Ingenia Elition X

Version/Model Number

781358

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

For Single-Use

-

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

K173356,K173451,K183063,K193215,K213516,K213583

Product Code

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Public Device Record Key

6000a5d3-8134-4b6b-b5a8-62d90989d4ff

Public Version Date

June 15, 2022

Public Version Number

6

DI Record Publish Date

April 25, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-