Catalog Number

K13-05253

Brand Name

Merit Medical®

Version/Model Number

00884450691502

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)

Yes

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

PYB

Product Code Name

Minor surgical procedures tray

Public Device Record Key

2697292c-3cf2-4e4e-96a0-cf64ea7444ae

Public Version Date

September 15, 2022

Public Version Number

1

DI Record Publish Date

September 07, 2022

Package DI Number

20884450691506

Quantity per Package

4

Contains DI Package

10884450691509

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-