Catalog Number

-

Brand Name

Mckesson

Version/Model Number

16-41

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)

Yes

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

57e467c1-5e99-40a7-bc15-a407d52ae943

Public Version Date

August 13, 2020

Public Version Number

1

DI Record Publish Date

August 05, 2020

Package DI Number

20612479168170

Quantity per Package

10

Contains DI Package

10612479168166

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box