DEVICE: Monarch™ Software Cart v2.1.5 (B634SW0032750201050)

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Device Record History
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Device Identifier (DI) Information
Monarch™ Software Cart v2.1.5
Version 2.1.5
In Commercial Distribution

AURIS HEALTH, INC.
B634SW0032750201050
HIBCC

1
015823456 *Terms of Use
Monarch™ Software Cart v2.1.5
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
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No
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No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
43265 Robotic surgical system application software
An individual application software program or group of programs, routines and/or algorithms designed for use in association with a robotic surgical system typically used in computer assisted surgery (CAS) during orthopaedic procedures so that this can function according to its intended purpose. This program can be permanently installed or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EOQ Bronchoscope (Flexible Or Rigid)
JAK System, X-Ray, Tomography, Computed
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K173760 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
fcb71e53-d29f-4193-b626-f531a7e38134
September 18, 2019
1
September 10, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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