Monarch Bronchscope 2.0/Monarch Platform (P2)

GUDID B634MON0000060

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)

AURIS HEALTH, INC.

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Primary Device IDB634MON0000060
NIH Device Record Keyd984e7f2-99fa-45e8-8953-f5cdb9a876f6
Commercial Distribution Discontinuation2020-07-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMonarch Bronchscope 2.0/Monarch Platform (P2)
Version Model NumberMON-000006
Company DUNS015823456
Company NameAURIS HEALTH, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB634MON0000060 [Primary]

FDA Product Code

EOQBronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-07-10
Device Publish Date2020-04-21

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