Catalog Number

-

Brand Name

NA

Version/Model Number

SIGNA Artist

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K163331,K202238

Product Code

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Public Device Record Key

db09f9e5-3222-4e3d-a809-d34bcdd8fed5

Public Version Date

October 20, 2022

Public Version Number

2

DI Record Publish Date

January 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-