Catalog Number

SANCGARAUA

Brand Name

CARDINAL HEALTH

Version/Model Number

SANCGARAUA

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"

Yes

For Single-Use

Yes

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

OIP

Product Code Name

Radiology diagnostic kit

Public Device Record Key

f4bc1936-f6c3-41d2-8632-bbb876ea3790

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

July 13, 2016

Package DI Number

50887488376071

Quantity per Package

3

Contains DI Package

10887488376073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE