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 Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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.

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
08906168451536Prima Swift surgical Microscope61825052026-07-19
08908006463572LABOMED eVO350 5-Step Slit lamp -Halogen (HL)81263002023-06-17
08906168451499Prima Lite Surgical Microscope61815012026-07-19
08906168451505Prima Lite Surgical Microscope Wall mount61815022026-07-19
08906168451512Prima Lite ENT Surgical Microscopes61825042026-07-19
08906168451529Prima Lite trainer61825122026-07-19
08906168451543Prima Pro surgical Microscope61836012026-07-19
08906168451550Prima Pro surgical Microscope61836032026-07-19
08906168451567Prima Floor Stand with Column6182001-8712026-07-19
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
08908006463152Labomed Magna Wall mount (Long Arm)61293012022-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906168451499Prima Lite Surgical MicroscopeLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451505Prima Lite Surgical Microscope Wall mountLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451512Prima Lite ENT Surgical MicroscopesLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451529Prima Lite trainerLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451536Prima Swift surgical MicroscopeLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451543Prima Pro surgical MicroscopeLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451550Prima Pro surgical MicroscopeLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451567Prima Floor Stand with ColumnLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
06945095527749zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527756zumaxZumax Medical Co., LTDFSO2026-07-06
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06945095528050zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528067zumaxZumax Medical Co., LTDFSO2026-07-06
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