FDA.reportPublic FDA data

Labomed Prima Mu ENT microscope

Primary DI
08908006463213
Brand
Labomed Prima Mu ENT microscope
Company
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Model
6212000
Device description
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
Published
2023-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

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
08908006463213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908006463213089080064632138908006463213

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical microscopeA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
919049606
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08908006463046Labomed Prima DNT Microscope Wall mount61371012022-12-13
08908006463053Labomed Prima DNT Microscope Ceiling Mount61372012022-12-13
08908006463077Labomed Prima DNT Microscope Wall mount long arm61371022022-12-13
08908006463084Labomed Prima DNT Microscope Ceiling Mount Long Arm61372022022-12-13
08908006463091Labomed Prima DNT Microscope Floor Mount Fixed61380012022-12-13
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
08908006463169Labomed Magna Floor stand with motorized filter (Standard arm)61291012022-12-15
08908006463176Labomed Magna Ceiling mount with motorized filter (Long arm)61292022022-12-15
08908006463183Labomed Magna Wall mount with motorized filter (Long arm)61293022022-12-15
08908006463572LABOMED eVO350 5-Step Slit lamp -Halogen (HL)81263002023-06-17
08908006463251Labomed Stella OPH microscope 62191002023-06-15
08908006463268Labomed Stella OPH microscope with wall mount 62191012023-06-15
08908006463008Labomed Prima ENT microscope 61370002023-06-14
08908006463244Labomed Magna Ceiling mount (Long Arm)61292012023-06-13
08908006463404Labomed Magna Floor stand with Fluorescence Observation61293042023-06-13
08908006463435Labomed Magna Dental Microscope wall mount long arm / fluorescence observation 61293062023-06-13

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