Monarch Software Tower v2.2.1

GUDID B634SW0121920202000

Monarch Software Tower v2.2.1

AURIS HEALTH, INC.

Robotic surgical system application software
Primary Device IDB634SW0121920202000
NIH Device Record Key418e555e-97d2-4b15-acfb-2db6adea6d17
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonarch Software Tower v2.2.1
Version Model NumberVersion 2.2.1
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB634SW0121920202000 [Primary]

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 Date2020-03-13
Device Publish Date2020-03-05

Devices Manufactured by AURIS HEALTH, INC.

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10810068810780 - Monarch™ Laptop P70 Linux USB Image v2.2.52024-02-26 Monarch™ Laptop P70 Linux USB Image v2.2.5
10810068810797 - Monarch™ Laptop P17/P73 Linux USB Image v2.2.52024-02-26 Monarch™ Laptop P17/P73 Linux USB Image v2.2.5
B634MON00000501R0 - Monarch Endoscopy Platform (P1) System, Refurbished2023-06-19 Monarch Endoscopy Platform (P1) System, Refurbished
10810068810476 - Monarch™ Software Tower v2.2.42023-02-13 Monarch™ Software Tower v2.2.4
10810068810483 - Monarch™ Software Cart v2.2.42023-02-13 Monarch™ Software Cart v2.2.4
10810068810490 - Monarch™ Laptop P70 Linux USB Image v2.2.42023-02-13 Monarch™ Laptop P70 Linux USB Image v2.2.4

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