Catalog Number

SAN58BSLO1

Brand Name

CARDINAL HEALTH

Version/Model Number

SAN58BSLO1

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

OEQ

Product Code Name

Angiography/angioplasty kit

Public Device Record Key

0827c16a-7f56-4293-97e1-452f0d8d89ec

Public Version Date

July 23, 2018

Public Version Number

2

DI Record Publish Date

May 15, 2018

Package DI Number

50887488995067

Quantity per Package

4

Contains DI Package

10887488995069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE