Catalog Number

SBAHDRBRV2

Brand Name

CARDINAL HEALTH

Version/Model Number

SBAHDRBRV2

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

Endoscope introducer kit

Public Device Record Key

6304b0e5-eba3-4b91-a973-1475671e1a8c

Public Version Date

July 20, 2018

Public Version Number

3

DI Record Publish Date

January 29, 2018

Package DI Number

50887488914242

Quantity per Package

1

Contains DI Package

10887488914244

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE