Catalog Number

-

Brand Name

Ingenia Ambition X

Version/Model Number

781356

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

K181479,K183063,K193215,K213583

Product Code

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Public Device Record Key

ef6a9388-3f81-4f04-889c-2004788ee4e0

Public Version Date

June 15, 2022

Public Version Number

4

DI Record Publish Date

August 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-