Catalog Number

SMA69LHKW5

Brand Name

CARDINAL HEALTH

Version/Model Number

SMA69LHKW5

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

OJF

Product Code Name

Hysterectomy kit

Public Device Record Key

de8eac6d-4f9b-406e-a34e-1ef039b3654a

Public Version Date

February 24, 2020

Public Version Number

1

DI Record Publish Date

February 14, 2020

Package DI Number

50888439748398

Quantity per Package

2

Contains DI Package

10888439748390

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE