Catalog Number

SMA23LDCMA

Brand Name

CARDINAL HEALTH

Version/Model Number

SMA23LDCMA

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

KKX

Product Code Name

Drape, surgical

Public Device Record Key

a157b22c-2c55-494c-b4b3-0991d86beed9

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

July 28, 2016

Package DI Number

50885425291937

Quantity per Package

15

Contains DI Package

10885425291939

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE