Catalog Number

SRI63IRUMB

Brand Name

CARDINAL HEALTH

Version/Model Number

SRI63IRUMB

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

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

9e526c16-1a7a-42bf-9c80-6cb85ec7c467

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

July 21, 2015

Package DI Number

50885425204647

Quantity per Package

4

Contains DI Package

00885425204642

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE