Labomed Prima DNT Microscope Floor Mount Fixed Long Arm

GUDID 08908006463107

The Prima DNT Microscope Floor Mount Fixed long Arm 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 microscope 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. INTENDED USE: Prima Surgical Microscope is an AC powered device intended for use during diagnosis and Surgeryto provide a magnified view of surgical field.

LABOTECH MICROSCOPES INDIA PRIVATE LIMITED

Dental surgical microscope
Primary Device ID08908006463107
NIH Device Record Keyc5f33200-1924-4f20-b135-f9030bdc92a1
Commercial Distribution Discontinuation2025-09-27
Commercial Distribution StatusNot in Commercial Distribution
Brand NameLabomed Prima DNT Microscope Floor Mount Fixed Long Arm
Version Model Number6138002
Company DUNS919049606
Company NameLABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108908006463107 [Primary]

FDA Product Code

FSOMicroscope, Surgical, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-09-29
Device Publish Date2022-12-13

Devices Manufactured by LABOTECH MICROSCOPES INDIA PRIVATE LIMITED

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08908006463107 - Labomed Prima DNT Microscope Floor Mount Fixed Long Arm2025-09-29The Prima DNT Microscope Floor Mount Fixed long Arm 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 microscope 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. INTENDED USE: Prima Surgical Microscope is an AC powered device intended for use during diagnosis and Surgeryto provide a magnified view of surgical field.
08908006463107 - Labomed Prima DNT Microscope Floor Mount Fixed Long Arm2025-09-29 The Prima DNT Microscope Floor Mount Fixed long Arm is a surgical and diagnostic microscope which is adaptable for different su

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