Catalog Number

-

Brand Name

Monarch Endoscopy Platform (P1) Tower Upgrade

Version/Model Number

MON-000005-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 09, 2020

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

K173760

Product Code

EOQ

Product Code Name

Bronchoscope (Flexible Or Rigid)

Public Device Record Key

105c1c53-dec4-4acc-845f-2cffa6618fa1

Public Version Date

July 10, 2020

Public Version Number

2

DI Record Publish Date

March 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-