Catalog Number

K13-04495

Brand Name

Merit Medical®

Version/Model Number

00884450383278

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

320ce7fe-5889-4b7a-be95-5e4992590349

Public Version Date

October 21, 2020

Public Version Number

2

DI Record Publish Date

September 27, 2018

Package DI Number

20884450383272

Quantity per Package

4

Contains DI Package

10884450383275

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-