Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-82764

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

KDD

Product Code Name

Kit, Surgical Instrument, Disposable

Public Device Record Key

608a300a-945b-4097-9e72-205ddb7a71fa

Public Version Date

October 01, 2019

Public Version Number

1

DI Record Publish Date

September 23, 2019

Package DI Number

00612479235427

Quantity per Package

20

Contains DI Package

00612479235410

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case