FDA.reportPublic FDA data

BIOM 6 HD Optic Set for f=175 mm

Primary DI
04049584035714
Brand
BIOM 6 HD Optic Set for f=175 mm
Company
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Model
10029900
Published
2026-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HOHSpectacle, Operating (Loupe), Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOHSpectacle, Operating (Loupe), OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049584035738PackageGS14In Commercial Distribution
04049584035714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049584035738040495840357384049584035738
04049584035714040495840357144049584035714

GMDN Terms#

Term, Definition table
TermDefinition
Microscope objectiveA lens or lens group that forms the part of the optical system of a microscope closest to the object. It is used to magnify the viewed image. The objective may be supplied singularly, in pairs, or in sets of increasing magnification.

Regulatory Flags#

DUNS number
317138956
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049584034953Pentacam Cornea OCT100190012026-03-31
04049584037909Cable SDI BIOM 6 for Alcon LuxOR Revalia100401382026-02-11
04049584037916Cable Y BIOM 6 for Haag Streit Metis 900100401372026-02-11
04049584037930Cable CAN BIOM 6 for Leica Proveo 8 / 8x100413192026-02-11
04049584037954Cable CTRL BIOM 6 for Leica Proveo 8 / 8x100432282026-02-11
04049584037961Cable Y BIOM 6 for Alcon LuxORRevalia100425572026-02-11
04049584038012Cable CAN BIOM 6 for B&L SeeLuma100428332026-02-11
04049584037695Focusing Module BIOM 6, 175 mm100351102026-01-23
04049584037701Focusing Module BIOM 6, 200 mm100379072026-01-23
04049584037718Precision Mount for B&L100394002026-01-23
04049584037725Precision Mount for Leica100390582026-01-23
04049584037732Precision Mount for Alcon100291772026-01-23
04049584037749Precision Mount for Zeiss100392342026-01-23
04049584037756Precision Mount for Haag Streit100291782026-01-23
04049584035721BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584035738BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035745BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584037152BIOM 6100348202026-01-14
04049584037251Twinfield 3100348192026-01-14
04049584034212GONIO ready® CL10012719100127202025-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049584035721BIOM 6 HD Optic Set for f=200 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2026-01-14
04049584035738BIOM 6 HD Optic Set for f=175 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2026-01-14
04049584035745BIOM 6 HD Optic Set for f=200 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2026-01-14
04049539106889EyeMag Smart TTLCarl Zeiss Meditec AGHOH2025-01-22
04049539106896EyeMag ClassicCarl Zeiss Meditec AGHOH2025-01-22
04049584029591BIOM ready+ 175, for f=175 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2024-09-11
04049584029607BIOM ready+ 200, for f=200 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2024-09-11
04049584029447BIOM ready+ 175, for f=175 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2024-09-11
04049584029454BIOM ready+ 200, for f=200 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2024-09-11
04049539101341EyeMag SmartCarl Zeiss Meditec AGHOH2023-11-08
04049539101358EyeMag Pro SCarl Zeiss Meditec AGHOH2023-11-08
04049539101365EyeMag Pro FCarl Zeiss Meditec AGHOH2023-11-08
00842962146866HNM MEDICALHNM STAINLESS, LLC.HOH2023-09-21
00810114911006SurgiTelSurgitelHOH2023-07-25
00810114911013SurgiTelSurgitelHOH2023-07-25
00810114911020SurgiTelSurgitelHOH2023-07-25
00810114911037SurgiTelSurgitelHOH2023-07-25
00810114911044SurgiTelSurgitelHOH2023-07-25
00810114911051SurgiTelSurgitelHOH2023-07-25
00810114911068SurgiTelSurgitelHOH2023-07-25
00810114911075SurgiTelSurgitelHOH2023-07-25
00810114911082SurgiTelSurgitelHOH2023-07-25
00810114911099SurgiTelSurgitelHOH2023-07-25
00810114911105SurgiTelSurgitelHOH2023-07-25
00810114911112SurgiTelSurgitelHOH2023-07-25
00810114911129SurgiTelSurgitelHOH2023-07-25
00810114911136SurgiTelSurgitelHOH2023-07-25
00810114910320SurgiTelSurgitelHOH2023-04-26
00810114910337SurgiTelSurgitelHOH2023-04-26
00810114910344SurgiTelSurgitelHOH2023-04-26