Catalog Number

-

Brand Name

Not Applicable

Version/Model Number

5494440

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

K142098

Product Code

OUO

Product Code Name

Tomographic imager combining emission computed tomography with nuclear magnetic resonance

Public Device Record Key

1dbf881a-de10-4c98-8c67-7cd58e3c06c9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-