Catalog Number

SBA12CBWCR

Brand Name

CARDINAL HEALTH

Version/Model Number

SBA12CBWCR

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

NWU

Product Code Name

Kit, introducer, endoscope

Public Device Record Key

358d4ae3-10fe-47a9-975a-d3713e88ed0a

Public Version Date

July 17, 2018

Public Version Number

3

DI Record Publish Date

July 12, 2016

Package DI Number

50885425930980

Quantity per Package

1

Contains DI Package

10885425930982

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE