Catalog Number

SMA44OCSLB

Brand Name

CARDINAL HEALTH

Version/Model Number

SMA44OCSLB

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

OKV

Product Code Name

Obstetrical kit

Public Device Record Key

f3003b99-4217-42ac-bafb-dade4c102b70

Public Version Date

January 11, 2019

Public Version Number

1

DI Record Publish Date

December 11, 2018

Package DI Number

50888439268773

Quantity per Package

4

Contains DI Package

10888439268775

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE