FDA.reportPublic FDA data

BIOM 6 HD Optic Set for f=175 mm

Primary DI
04049584035738
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
Rx
false
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317138956
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
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
04049584035714BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035721BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
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
04049584035714BIOM 6 HD Optic Set for f=175 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2026-01-14
04049584035721BIOM 6 HD Optic Set for f=200 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