Catalog Number

DYNJP2316

Brand Name

Medline

Version/Model Number

DYNJP2316

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

04db5d74-0cf8-4929-9902-fd81e2646bd2

Public Version Date

February 16, 2021

Public Version Number

1

DI Record Publish Date

February 08, 2021

Package DI Number

40080196745495

Quantity per Package

24

Contains DI Package

10080196745494

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE