Catalog Number

28MC21150SN-I

Brand Name

Merit Maestro®

Version/Model Number

00884450357392

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

65a0cb98-b287-4776-bba8-b0f3f8575550

Public Version Date

March 21, 2019

Public Version Number

2

DI Record Publish Date

September 26, 2018

Package DI Number

10884450357399

Quantity per Package

10

Contains DI Package

00884450357392

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-