Catalog Number

SMACNVHEH5

Brand Name

CARDINAL HEALTH

Version/Model Number

SMACNVHEH5

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

ac180dda-ae10-4c1e-8bba-960322a27907

Public Version Date

January 07, 2022

Public Version Number

1

DI Record Publish Date

December 30, 2021

Package DI Number

50195594482372

Quantity per Package

6

Contains DI Package

10195594482374

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE