DEVICE: Monarch Endoscopy Platform (P1) System, Refurbished (B634MON00000501R0)

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Device Record History
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Device Identifier (DI) Information
Monarch Endoscopy Platform (P1) System, Refurbished
MON-000005-01R
In Commercial Distribution

Auris Health, Inc.
B634MON00000501R0
HIBCC

1
015823456 *Terms of Use
Monarch Endoscopy Platform (P1) System, Refurbished
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
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?
38678 Robotic surgical arm system
An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.
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
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
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
918c4fb6-ba98-4952-8212-ef6bc52f828d
September 01, 2025
3
March 25, 2020
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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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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