Monarch Advanced Imaging Accessory Kit MON-000709

GUDID B634MON0007091

Window Field Generator, Connection Cable, Mounting System

AURIS HEALTH, INC.

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Primary Device IDB634MON0007091
NIH Device Record Keye66064c2-93bf-4afd-9cfc-568c532fe6bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonarch Advanced Imaging Accessory Kit
Version Model NumberMON-000709
Catalog NumberMON-000709
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
HIBCCB634MON0007090 [Primary]
HIBCCB634MON0007091 [Package]
Contains: B634MON0007090
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-23
Device Publish Date2021-07-15

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