Catalog Number

-

Brand Name

N/A

Version/Model Number

9734215

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

K032541

Product Code

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Public Device Record Key

c7d530fc-a92c-48f9-9565-f28479dba8d2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-