Duns Number:015823456
Device Description: The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.Monarch Bronchscope 2.0/Monarch Platform (P2)
Catalog Number
-
Brand Name
Monarch Bronchscope 2.0/Monarch Platform (P2)
Version/Model Number
MON-000006
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
-
Product Code
EOQ
Product Code Name
Bronchoscope (Flexible Or Rigid)
Public Device Record Key
d984e7f2-99fa-45e8-8953-f5cdb9a876f6
Public Version Date
July 10, 2020
Public Version Number
2
DI Record Publish Date
April 21, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 37 |