Catalog Number

-

Brand Name

Sun Nuclear CT Electron Density Phantom

Version/Model Number

467

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

LHO

Product Code Name

Instrument, Quality-Assurance, Radiologic

Public Device Record Key

b81c0b20-eb68-4f30-b15b-f95b79f6cb93

Public Version Date

March 22, 2021

Public Version Number

1

DI Record Publish Date

March 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-