Catalog Number

SBM11BMHKI

Brand Name

CARDINAL HEALTH

Version/Model Number

SBM11BMHKI

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

GAA

Product Code Name

NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Public Device Record Key

3f6e06e6-7da0-4ab2-a921-973f42b995f3

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

July 20, 2016

Package DI Number

50887488519584

Quantity per Package

20

Contains DI Package

10887488519586

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE