DEVICE: Labomed Magna Ceiling mount (Standard Arm) (08908006463121)
Device Identifier (DI) Information
Labomed Magna Ceiling mount (Standard Arm)
6129200
In Commercial Distribution
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
6129200
In Commercial Distribution
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Labomed Magna DNT Ceiling mount (Standard Arm) microscope is a surgical and diagnostic microscope that is adaptable for different surgical needs for consistent visualization during all intraoperative phases of endodontics by providing a magnified view of the surgical field without compromising performance. The microscope provides extremely high optical image quality, good depth of focus, and a wide field of view for precise surgery. Illumination control and high eye point of the observation head helps reduce the user's work fatigue and allows comfortable use over a long period.
Salient features of this microscope are:
1. The observation head can easily be positioned with the help of a suspension arm.
2. An advanced Galilean Zoom 1:6, also convertible to 8 step magnichanger allows optimal magnification for various needs at different magnification levels.
3. Cold light illumination with a high intensity 50W LED lamp is provided using a fiber optic guide for proper illumination.
4. An effortless articulating system ABA (Automatic Balancing Arm) features an electromagnetic brake system that enables the ultimate flexibility in manuvering the microscope's viewing angle and position.
5. The Labomed NuVar CMO with variable working distance objective comes standard, and provides user greater convenience in achieving a comfortable working distance.
6. When the microscope is not in use, the suspension arm can be folded over the main body for compact storage.
Intended Use:
The Magna microscope is an AC powered device intended for use during diagnosis and surgery to provide a magnified view of the region of interest.
Device Characteristics
MR Safe | |
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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? |
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62439 | Dental surgical microscope |
A light (optical) magnification instrument intended to be used to magnify and visualize minute intraoral structures during dental examination and dental surgical procedures via transmission of white and/or ultraviolet light. It typically consists of a control unit, eyepiece and magnification controls, and a white and fluorescent light module to enable differentiation of natural tooth material suggesting dental pathology (e.g., caries, plaque, calculus/tartar) or composite material used for dental repairs. It may also include a camera for still image capture or video recording.
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FDA Product Code
[?]Product Code | Product Code Name |
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FSO | Microscope, Surgical, General & Plastic Surgery |
FDA Premarket Submission
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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Device Record Status
63742a8c-f54a-42f1-9571-58e0f3b26702
December 21, 2022
1
December 13, 2022
December 21, 2022
1
December 13, 2022
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined