DEVICE: Labomed Prima Mu ENT microscope (08908006463213)
Device Identifier (DI) Information
Labomed Prima Mu ENT microscope
6212000
In Commercial Distribution
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
6212000
In Commercial Distribution
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Labomed Prima Mu ENT microscope
- '- MaxLite(TM) optics,3 step magnification: 0.6x, 1.0x, 1.6x
- 27W LED illumination (cold light), 100V-240V AC universal power supply
- Straight binocular head, IPD 50-75mm
- f=250mm CMO with manual fine focus knob and sterilizable cap
- WF 10x/18mm eyepieces with foldable eyeguard
- Swivel arm (380mm Long, 360° rotation), suspension arm (600mm Long, clockwise 70° and - 180° rotation) with locking/tension control knobs and LED shut-off in park position
- Carrier arm and ± 155° coupling with tension adjustment locks
- Floor stand with H-shape base on castor wheels with brakes
- Yellow or Green filter, dust cover, and sterilizable knob caps
Device Characteristics
MR Safe | |
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? |
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35191 | General-purpose surgical microscope |
A general-purpose, surgical, light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures, e.g., nerves or vessels in the performance of delicate surgical procedures which require high magnification by transmitted light. An operating microscope will often be equipped with motorized focusing, adjustable magnification mechanisms (manual, zoom or both), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FSO | Microscope, Surgical, General & Plastic Surgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
974d801d-0a91-4289-9e94-34c8be387604
June 22, 2023
1
June 14, 2023
June 22, 2023
1
June 14, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined