Catalog Number

K13-04301

Brand Name

Merit Medical®

Version/Model Number

00884450322512

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

8dad4534-3ca6-4d36-897e-d44c0e99ccdb

Public Version Date

October 21, 2020

Public Version Number

2

DI Record Publish Date

September 14, 2018

Package DI Number

10884450322519

Quantity per Package

25

Contains DI Package

00884450322512

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-