Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-8265

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

052e71bf-1765-4902-851e-609a6b1e78b6

Public Version Date

September 08, 2022

Public Version Number

1

DI Record Publish Date

August 31, 2022

Package DI Number

40612479124682

Quantity per Package

20

Contains DI Package

20612479124541

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case