Catalog Number

-

Brand Name

Sun Nuclear Sono403 Multi-Purpose Phantom SCG

Version/Model Number

403GSLE

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

IXG

Product Code Name

Phantom, Anthropomorphic, Radiographic

Public Device Record Key

f91c2e68-4519-4776-ba0d-4a8e07e6d082

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-