Catalog Number

K13-04593

Brand Name

Merit Medical®

Version/Model Number

00884450407172

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

fd40a834-2a64-404d-be22-875565b7bcb8

Public Version Date

October 21, 2020

Public Version Number

2

DI Record Publish Date

April 23, 2019

Package DI Number

10884450407179

Quantity per Package

25

Contains DI Package

00884450407172

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-