Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-i80-12401-S

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

PUI

Product Code Name

Drape, Surgical, Exempt

Public Device Record Key

1ee2eada-d770-4b99-a7e7-3677da91130e

Public Version Date

August 01, 2022

Public Version Number

4

DI Record Publish Date

April 25, 2019

Package DI Number

40612479241471

Quantity per Package

22

Contains DI Package

10612479241463

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case