Catalog Number

-

Brand Name

Monarch™ System

Version/Model Number

PMACS1IE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

BYI

Product Code Name

PERCUSSOR, POWERED-ELECTRIC

Public Device Record Key

830cd034-0f10-46c2-a0be-1532a2e4da63

Public Version Date

January 28, 2021

Public Version Number

1

DI Record Publish Date

January 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-