Labomed Prima Mu DNT Microscope

GUDID 08908006463206

The LABOMED Prima Mu DNT is a surgical and diagnostic microscope which is adaptable for different surgical needs for consistent visualization during all intra operative phases of dentistry surgeries by providing magnified view of the surgical field without compromise to performance. The microscope provides extremely high optical image quality, good depth of focus and wide field of view for precise surgery. Illumination control, inbuilt tilt, adjustment of the observation head help to reduce the Surgeon's work fatigue and allow comfortable use over 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 5-step magnification changer allows an optimal magnification for a particular surgery from five different magnifications. 3. Cold light illumination with a high intensity 50W LED lamp is provided in magnichanger for proper illumination. The illumination is further adjustable up to its most suitable brightness using intensity control knob suitably located at the suspension arm, and is easily approachable to the surgeon. 4. When the colposcope is not in use, the suspension arm can be folded over the main body to store it compactly. 5. Dual iris Diaphragm allows greater depth of field particularly valuable for photography. 6. Rigid H-form base with castor wheels provides greater stability as well as mobility to the instrument. INTENDED USE Prima Mu ENT/DNT Surgical Microscope is an AC powered device intended for use during diagnosis and Surgery to provide a magnified view of surgical field. .

LABOTECH MICROSCOPES INDIA PRIVATE LIMITED

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• Primary Device ID: 08908006463206
• NIH Device Record Key: d77cec8d-a920-4e59-8dc9-b1447477b875
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Labomed Prima Mu DNT Microscope
• Version Model Number: 6211000
• Company DUNS: 919049606
• Company Name: LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08908006463206 [Primary]

FDA Product Code

• FSO: Microscope, Surgical, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-15
• Device Publish Date: 2022-12-12

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