FDA.reportPublic FDA data

Labomed Magna Wall mount (Standard Arm)

Primary DI
08908006463138
Brand
Labomed Magna Wall mount (Standard Arm)
Company
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Model
6129300
Published
2022-12-13
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
08908006463138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908006463138089080064631388908006463138

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.

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
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
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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