Catalog Number

K10-05960

Brand Name

Merit Medical®

Version/Model Number

00884450555774

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PPD

Product Code Name

Universal drainage tray

Public Device Record Key

b369eed9-4fd5-445a-96d8-b71719d6cc2e

Public Version Date

May 26, 2021

Public Version Number

1

DI Record Publish Date

May 18, 2021

Package DI Number

20884450555778

Quantity per Package

4

Contains DI Package

10884450555771

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-