Labomed Prima ENT microscope

GUDID 08908006463008

Prima ENT microscope - MaxLite(TM) optics, 5 step magnification: 0.4x, 0.6x, 1.0x, 1.6x, 2.5x - 50W LED coaxial 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 diopter lock and foldable eyeguard - Swivel arm (525mm Long, 360 degree rotation) and suspension arm (600mm Long, 320 degree rotation) with locking/tension control knobs and LED shut-off in park position - Carrier arm and 120 degree coupling with tension adjustment locks, T-handle /Ergo Handle control - Floor stand with H-shape base on castor wheels with brakes - Yellow and Green sliding filters, dust cover, and sterilizable knob caps

LABOTECH MICROSCOPES INDIA PRIVATE LIMITED

General-purpose surgical microscope

• Primary Device ID: 08908006463008
• NIH Device Record Key: 6facb408-2cd2-4365-972c-6daa4f59b792
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Labomed Prima ENT microscope
• Version Model Number: 6137000
• 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	08908006463008 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-22
• Device Publish Date: 2023-06-14

Devices Manufactured by LABOTECH MICROSCOPES INDIA PRIVATE LIMITED

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