FDA.reportPublic FDA data

OPMI LUMERA 300

Primary DI
06977585090013
Brand
OPMI LUMERA 300
Company
Carl Zeiss Meditec (Suzhou) Co., Ltd.
Model
6137
Device description
No description
Published
2025-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSOMicroscope, Surgical, General & Plastic Surgery
HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977585090013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977585090013069775850900136977585090013

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
631835173
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
06977585090051EXTARO 30060332025-03-26
06977585090099EXTARO 30060342025-03-26
06977585090129EXTARO 30060352025-03-26
06977585090136EXTARO 300000000-2327-7552025-03-26
06977585090143Fluorescence Mode000000-2165-3872025-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095528944zumaxZumax Medical Co., LTDFSO2026-10-10
06945095528951zumaxZumax Medical Co., LTDFSO2026-10-10
06945095528968zumaxZumax Medical Co., LTDFSO2026-10-10
06945095535904zumaxZumax Medical Co., LTDHRM2026-10-10
06945095535928zumaxZumax Medical Co., LTDHRM2026-10-10
06945095528869zumaxZumax Medical Co., LTDFSO2026-10-09
06945095528920zumaxZumax Medical Co., LTDFSO2026-10-09
06945095528937zumaxZumax Medical Co., LTDFSO2026-10-09
04547451338697INAMIINAMI & CO., LTD.HRM2026-10-01
06945095528975zumaxZumax Medical Co., LTDFSO2026-09-29
06945095528982zumaxZumax Medical Co., LTDFSO2026-09-29
06945095529002zumaxZumax Medical Co., LTDFSO2026-09-29
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
06945095527763zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527787zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527794zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527817zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527848zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527879zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527886zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527893zumaxZumax Medical Co., LTDFSO2026-07-06