Catalog Number

SMA13VHEM9

Brand Name

CARDINAL HEALTH

Version/Model Number

SMA13VHEM9

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

331296ce-ca02-4171-9efe-51aa9dbf35a8

Public Version Date

December 24, 2021

Public Version Number

1

DI Record Publish Date

December 16, 2021

Package DI Number

50195594469786

Quantity per Package

2

Contains DI Package

10195594469788

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE