Catalog Number

K09-10796A

Brand Name

Merit Medical®

Version/Model Number

00884450397305

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

OJV

Product Code Name

Single use instrument tray

Public Device Record Key

3ee75eb7-c6dd-459e-9b9e-f5cedf073ca8

Public Version Date

November 05, 2018

Public Version Number

1

DI Record Publish Date

October 03, 2018

Package DI Number

20884450397309

Quantity per Package

4

Contains DI Package

10884450397302

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-