AccessGUDID - DEVICE: Monarch Advanced Imaging Accessory Kit (B634MON0007090)

GUDID

Device Identifier (DI) Information

Brand Name: Monarch Advanced Imaging Accessory Kit
Version or Model: MON-000709
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MON-000709
Company Name: AURIS HEALTH, INC.

Primary DI Number: B634MON0007090
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015823456 *Terms of Use

Device Description: Window Field Generator, Connection Cable, Mounting System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
EOQ	Bronchoscope (Flexible Or Rigid)
JAK	System, X-Ray, Tomography, Computed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211493	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e66064c2-93bf-4afd-9cfc-568c532fe6bd
Public Version Date: June 19, 2023
Public Version Number: 2
DI Record Publish Date: July 15, 2021