SeeLuma Digital Binoculars Module

GUDID 04064434000193

SeeLuma Digital Binoculars Module is an accessory for the surgical microscope SeeLuma.

Munich Surgical Imaging GmbH

Ophthalmic surgical microscope
Primary Device ID04064434000193
NIH Device Record Key777add66-a5a3-447f-b702-6d028d94fef4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeeLuma Digital Binoculars Module
Version Model NumberV12201-02
Company DUNS315155571
Company NameMunich Surgical Imaging GmbH
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104064434000193 [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 Date2025-08-13
Device Publish Date2025-08-05

On-Brand Devices [SeeLuma Digital Binoculars Module]

04064434000148SeeLuma Digital Binoculars Module is an accessory for the surgical microscope SeeLuma.
04064434000193SeeLuma Digital Binoculars Module is an accessory for the surgical microscope SeeLuma.

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