Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-GDF-01

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

6a7c93a9-cc28-4e79-807f-686e561ef8bf

Public Version Date

February 24, 2021

Public Version Number

1

DI Record Publish Date

February 16, 2021

Package DI Number

00612479258969

Quantity per Package

20

Contains DI Package

00612479258952

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case