FDA.reportPublic FDA data

Labomed Prima OPH microscope (Basic, motorized fine focus)

Primary DI
08908006463312
Brand
Labomed Prima OPH microscope (Basic, motorized fine focus)
Company
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Model
6136000
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 - Z-Axis motorized 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 Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
08908006463312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908006463312089080064633128908006463312

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.

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
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
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
08908006463589LABOMED eVO450 5-Step Slit lamp -Halogen (HL)81273002023-06-17
08908006463251Labomed Stella OPH microscope62191002023-06-15
08908006463268Labomed Stella OPH microscope with wall mount62191012023-06-15
08908006463329Labomed Prima OPH microscope (Motorized fine focus & X-Y coupling)61350002023-06-15

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04049584037152BIOM 6OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-14
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06972039971061MOPTIMShenzhen CERTAINN Technology Co., Ltd.HRM2025-06-23
06972039971078MOPTIMShenzhen CERTAINN Technology Co., Ltd.HRM2025-06-23
06972039971221MOPTIMShenzhen CERTAINN Technology Co., Ltd.HRM2025-06-23
01836230004391Microscope Cover MITAKA 137/380 HLTPHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16
01836230004407Microscope Cover MITAKA mm80, mm90, 80/276PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16
02836230004390Microscope Cover MITAKA 137/380 HLTPHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16
02836230004406Microscope Cover MITAKA mm80, mm90, 80/276PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16