Catalog Number

MRB-000211-A

Brand Name

Monarch Bronchoscope

Version/Model Number

MBR-000211-A

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

K193534,K193534

Product Code

EOQ

Product Code Name

Bronchoscope (Flexible Or Rigid)

Public Device Record Key

7fbda138-323c-4228-a398-7c270edf70cd

Public Version Date

May 13, 2021

Public Version Number

1

DI Record Publish Date

May 05, 2021

Package DI Number

B634MBR000211A1

Quantity per Package

1

Contains DI Package

B634MBR000211A0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box