BIOM 6

GUDID 04049584037152

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Ophthalmic surgical microscope
Primary Device ID04049584037152
NIH Device Record Key2dba6d35-e40c-4414-9cd6-f3a8915f1b17
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOM 6
Version Model Number10034820
Company DUNS317138956
Company NameOCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104049584037152 [Primary]

FDA Product Code

HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-22
Device Publish Date2026-01-14

Devices Manufactured by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

04049584037695 - Focusing Module BIOM 6, 175 mm2026-02-02
04049584037701 - Focusing Module BIOM 6, 200 mm2026-02-02
04049584037718 - Precision Mount for B&L2026-02-02
04049584037725 - Precision Mount for Leica2026-02-02
04049584037732 - Precision Mount for Alcon2026-02-02
04049584037749 - Precision Mount for Zeiss2026-02-02
04049584037756 - Precision Mount for Haag Streit2026-02-02
04049584035738 - BIOM 6 HD Optic Set for f=175 mm2026-01-22

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