Catalog Number

07-9221A

Brand Name

CARDINAL HEALTH

Version/Model Number

07-9221A

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

KOA

Product Code Name

SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Public Device Record Key

1ae36dc7-d996-4c97-bc22-7e1d91ee5db0

Public Version Date

November 18, 2019

Public Version Number

1

DI Record Publish Date

November 08, 2019

Package DI Number

50888439545690

Quantity per Package

10

Contains DI Package

10888439545692

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE