Catalog Number

-

Brand Name

Monarch™ System

Version/Model Number

1000

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

-

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

BYI

Product Code Name

PERCUSSOR, POWERED-ELECTRIC

Public Device Record Key

8a0ef9f0-eb94-4ff4-b825-e666dfcd2049

Public Version Date

March 18, 2020

Public Version Number

3

DI Record Publish Date

May 08, 2017

Package DI Number

00887761981522

Quantity per Package

1

Contains DI Package

00887761019867

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-