Catalog Number

MBR-000211-B

Brand Name

Monarch Bronchoscope

Version/Model Number

MBR-000211-B

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

K203614,K203614

Product Code

QNW

Product Code Name

Reprocessed Bronchoscope

Public Device Record Key

1286f1d6-065a-41c7-b223-e10d90a0e453

Public Version Date

May 21, 2021

Public Version Number

1

DI Record Publish Date

May 13, 2021

Package DI Number

B634MBR000211B1

Quantity per Package

1

Contains DI Package

B634MBR000211B0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box