FDA.reportPublic FDA data

OPMI® LUMERA® 300

Primary DI
06909262061375
Brand
OPMI® LUMERA® 300
Company
Carl Zeiss Suzhou Co., Ltd.
Model
6137
Device description
No description
Published
2022-08-11
Public version status
Update
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
06909262061375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06909262061375069092620613756909262061375

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, surgicalAn electrically-powered ophthalmic magnification instrument, usually stereoscopic, designed for use in the operating room (OR) to magnify minute structures within the eye or its surroundings in the performance of ophthalmic surgical procedures which require high magnification by transmitted light. It is typically equipped with motorized focusing, adjustable magnification mechanisms (zoom), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528182577
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
06909262200088Zeiss AxiovertAxiovert 5431030-9060-0002026-07-23
06909262200132Zeiss AxiovertAxiovert 5431030-9120-0002026-07-23
06909262200187ZEISS Primostar 3Primostar 3415501-0001-0002026-07-23
06909262200194ZEISS Primostar 3Primostar 3415501-0081-0002026-07-23
06909262200200ZEISS Primostar 3Primostar 3415501-0011-0002026-07-23
06909262200217ZEISS Primostar 3Primostar 3415501-0061-0002026-07-23
06909262200224ZEISS Primostar 3Primostar 3415501-0051-0002026-07-23
06909262200255ZEISS Primostar 3Primostar 3415501-0071-0002026-07-23
06909262200262ZEISS Primostar 3Primostar 3415501-0041-0002026-07-23
06909262200279ZEISS Primostar 3Primostar 3415501-0021-0012026-07-23
06909262200309ZEISS Primostar 3Primostar 3415501-0031-0012026-07-23
06909262200347ZEISS Primostar 3Primostar 3415501-0091-0002026-07-23
06909262200354ZEISS Primostar 3Primostar 3415501-0231-0002026-07-23
06909262200385ZEISS AxiolabAxiolab 5430037-9130-0002026-07-23
06909262200613Zeiss Primostar 1Primostar 1415501-0121-0002026-07-23
06909262200620ZEISS Primostar 1Primostar 1415501-0131-0002026-07-23
06909262200156Zeiss AxiovertAxiovert 5431030-9050-0002026-05-19
06909262060330EXTARO® 30060332022-08-11
06909262060347EXTARO® 30060342022-08-11
06909262060354EXTARO® 30060352022-08-11

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
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06945095527756zumaxZumax Medical Co., LTDFSO2026-07-06
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06945095527817zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527848zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527879zumaxZumax Medical Co., LTDFSO2026-07-06
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06945095527893zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527909zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527916zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527954zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528005zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528012zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528029zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528036zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528043zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528050zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528067zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528074zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528081zumaxZumax Medical Co., LTDFSO2026-07-06