Catalog Number

28MC2415045-I

Brand Name

Merit Maestro®

Version/Model Number

00884450315989

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

99e233db-ba31-438b-aaa3-21f7ca68ddfe

Public Version Date

March 21, 2019

Public Version Number

2

DI Record Publish Date

September 26, 2018

Package DI Number

10884450315986

Quantity per Package

1

Contains DI Package

00884450315989

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-