Catalog Number

K13-05082

Brand Name

Merit Medical®

Version/Model Number

00884450557518

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

PYB

Product Code Name

Minor surgical procedures tray

Public Device Record Key

d031a587-1586-4bf7-a990-9738c7ebc0a1

Public Version Date

March 24, 2021

Public Version Number

1

DI Record Publish Date

March 16, 2021

Package DI Number

20884450557512

Quantity per Package

4

Contains DI Package

10884450557515

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-