NA - SIGNA Hero System Medical Device Assembly - MDR - GENERAL ELECTRIC COMPANY

Duns Number:160032025

Device Description: SIGNA Hero System Medical Device Assembly - MDR

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

SIGNA Hero

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K213668

Product Code Details

Product Code

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Device Record Status

Public Device Record Key

96409d15-99e2-438d-9ad1-f4a2c6fae2ac

Public Version Date

February 21, 2022

Public Version Number

1

DI Record Publish Date

February 11, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENERAL ELECTRIC COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 81