FDA.reportPublic FDA data

Labomed Prima OPH microscope (Motorized fine focus & X-Y coupling)

Primary DI
08908006463329
Brand
Labomed Prima OPH microscope (Motorized fine focus & X-Y coupling)
Company
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Model
6135000
Device description
- MaxLite(TM) optics, 5 step magnification: 0.4x, 0.6x, 1.0x, 1.6x, 2.5x - RedReflex optical system- 50W LED coaxial illumination (cold light), 100V-240V AC universal power supply- 45° inclined binocular head, IPD 55-75mm - f=200mm CMO - WF 10x/16mm eyepieces with diopter lock and foldable eyeguard - Swivel arm (525mm Long, 360° rotation) and suspension arm (600mm Long, 320° rotation) with locking/tension control knobs and LED shut-off in park position - Motorized carrier with XY reset button; foot pedal with joystick to control XY; up/down pedals to control fine focus- Floor stand with H-shape base on castor wheels with brakes - Blue and Green sliding filters, dust cover, and sterilizable knob caps
Published
2023-06-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRMMicroscope, Operating & Accessories, Ac-Powered, OphthalmicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908006463329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908006463329089080064633298908006463329

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical microscopeAn electrically-powered ophthalmic magnification instrument, usually stereoscopic, designed for use in the operating room (OR) to magnify structures within the eye or its surroundings, and/or provide slit-lamp functionality to delineate intraocular structures or defects, during ophthalmic surgical procedures. It can be fixed or mobile (on wheels) and is typically equipped with motorized controls (foot-switch) for adjusting focus, magnification [zoom], illumination, and position, and with articulating arms; some types have integrated video cameras along with digital imaging and user interface screens.

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
08908006463213Labomed Prima Mu ENT microscope 62120002023-06-14
08908006463244Labomed Magna Ceiling mount (Long Arm)61292012023-06-13
08908006463404Labomed Magna Floor stand with Fluorescence Observation61293042023-06-13

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