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Monarch™ Software Tower v2.1.2

FDA UDI

Class II (US FDA UDI)

by Auris Health, Inc.

Identity

Trade Name
Monarch™ Software Tower v2.1.2 FDA UDI
Generic Name
Robotic surgical system application software FDA UDI
Device Name
Monarch™ Software Tower v2.1.2 FDA UDI
Model / Reference
Version 2.1.2 FDA UDI
Description
Monarch™ Software Tower v2.1.2 FDA UDI

Identifiers

Primary DI / UDI-DI
B634SW0032740201020 FDA UDI
510(k) Number
K173760 FDA UDI
FDA Product Code
JAK FDA UDI
EOQ FDA UDI
GMDN Term
Robotic surgical system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1750 FDA UDI
874.4680 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Robotic surgical system application software

Monarch™ Software Tower v2.1.2 by Auris Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Robotic surgical system application software.

Cleared under the same submission

K173760 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Auris Health, Inc.

Sources (1)

  • FDA UDI 5bd595cd-9317-4da9-bd5e-b64f1a91d4e2 34 fields · synced Jun 8, 2026