Catalog Number

782109

Brand Name

Ingenia

Version/Model Number

Ingenia Ambition X

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

-

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

K193215,K213583

Product Code

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Public Device Record Key

5ef615a8-2b24-4be3-8fb3-7a91475928f3

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

May 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-