Catalog Number

MON-000709

Brand Name

Monarch Advanced Imaging Accessory Kit

Version/Model Number

MON-000709

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

-

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

K211493,K211493

Product Code

EOQ

Product Code Name

Bronchoscope (Flexible Or Rigid)

Public Device Record Key

e66064c2-93bf-4afd-9cfc-568c532fe6bd

Public Version Date

July 23, 2021

Public Version Number

1

DI Record Publish Date

July 15, 2021

Package DI Number

B634MON0007091

Quantity per Package

1

Contains DI Package

B634MON0007090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box