FDA.reportPublic FDA data

LABOMED eVO350 5-Step Slit lamp -Halogen (HL)

Primary DI
08908006463572
Brand
LABOMED eVO350 5-Step Slit lamp -Halogen (HL)
Company
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Model
8126300
Published
2023-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
PUEBiomicroscope, Slit-Lamp, Ac-Powered, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUEBiomicroscope, Slit-Lamp, Ac-Powered, ExemptOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908006463572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908006463572089080064635728908006463572

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic examination slit lampAn electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye by viewing through the pupil; it is not dedicated to surgical procedures. It projects a narrow slit of light into the eye and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular structures. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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
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
08908006463435Labomed Magna Dental Microscope wall mount long arm / fluorescence observation 61293062023-06-13

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Primary DI, Brand, Company table
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