Catalog Number

DYNJZ46811A

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJZ46811A

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"

-

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

PUI

Product Code Name

Drape, surgical, exempt

Public Device Record Key

cbd8e5f6-3bfb-48dc-8455-d96d6f8f07ad

Public Version Date

August 12, 2022

Public Version Number

1

DI Record Publish Date

August 04, 2022

Package DI Number

40193489842686

Quantity per Package

30

Contains DI Package

10193489842685

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE