Catalog Number

MBR-000011

Brand Name

Monarch™ Bronchoscope System

Version/Model Number

MBR-000011

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K173760,K173760

Product Code

EOQ

Product Code Name

Bronchoscope (Flexible Or Rigid)

Public Device Record Key

51249d3b-b127-4ed2-9b09-3da9af09a991

Public Version Date

July 09, 2018

Public Version Number

1

DI Record Publish Date

June 08, 2018

Package DI Number

B634MBR0000111

Quantity per Package

1

Contains DI Package

B634MBR0000110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box