Catalog Number

MBR-000211-A

Brand Name

Monarch Bronchoscope

Version/Model Number

MBR-000211-A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 05, 2021

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

K193534

Product Code

EOQ

Product Code Name

Bronchoscope (Flexible Or Rigid)

Public Device Record Key

015ad568-62ac-40e9-af0b-6485e32bc767

Public Version Date

May 06, 2021

Public Version Number

2

DI Record Publish Date

March 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-