Catalog Number

9216

Brand Name

CARDINAL HEALTH

Version/Model Number

9216

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 12, 2022

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FYF

Product Code Name

CAP, SURGICAL

Public Device Record Key

7200a40c-d1f5-4d53-82ee-651c68988ffe

Public Version Date

June 13, 2022

Public Version Number

4

DI Record Publish Date

November 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-