Catalog Number

K10-05646A

Brand Name

Merit Medical®

Version/Model Number

00884450696705

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

ac61a2c5-6448-4136-b01b-00453b6b4ade

Public Version Date

September 23, 2022

Public Version Number

1

DI Record Publish Date

September 15, 2022

Package DI Number

10884450696702

Quantity per Package

15

Contains DI Package

00884450696705

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-