Labomed Prima DNT Microscope Floor Mount Fixed

Primary DI
08908006463091
Brand
Labomed Prima DNT Microscope Floor Mount Fixed
Company
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Model
6138001
Device description
The Labomed Prima DNT Microscope Floor Mount Fixed 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.
Published
2022-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FSOMicroscope, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSOMicroscope, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908006463091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908006463091089080064630918908006463091

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical microscopeA 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.

Regulatory Flags#

DUNS number
919049606
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08906168451536Prima Swift surgical Microscope61825052026-07-19
08908006463572LABOMED eVO350 5-Step Slit lamp -Halogen (HL)81263002023-06-17
08906168451499Prima Lite Surgical Microscope61815012026-07-19
08906168451505Prima Lite Surgical Microscope Wall mount61815022026-07-19
08906168451512Prima Lite ENT Surgical Microscopes61825042026-07-19
08906168451529Prima Lite trainer61825122026-07-19
08906168451543Prima Pro surgical Microscope61836012026-07-19
08906168451550Prima Pro surgical Microscope61836032026-07-19
08906168451567Prima Floor Stand with Column6182001-8712026-07-19
08908006463022Labomed Prima DNT Microscope Mobile Mount61380002022-12-12
08908006463046Labomed Prima DNT Microscope Wall mount61371012022-12-13
08908006463053Labomed Prima DNT Microscope Ceiling Mount61372012022-12-13
08908006463060Labomed Prima DNT Microscope Table Mount61675002022-12-13
08908006463077Labomed Prima DNT Microscope Wall mount long arm61371022022-12-13
08908006463084Labomed Prima DNT Microscope Ceiling Mount Long Arm61372022022-12-13
08908006463107Labomed Prima DNT Microscope Floor Mount Fixed Long Arm61380022022-12-13
08908006463114Labomed Magna Floor stand standard arm Microscope61291002022-12-13
08908006463121Labomed Magna Ceiling mount (Standard Arm)61292002022-12-13
08908006463138Labomed Magna Wall mount (Standard Arm)61293002022-12-13
08908006463152Labomed Magna Wall mount (Long Arm)61293012022-12-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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