3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)

GUDID 04560126269102

TOPCON CORPORATION

Ophthalmic spectral-domain optical coherence tomography system
Primary Device ID04560126269102
NIH Device Record Key95f45575-2433-41ec-a6c1-7b2f961686f2
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)
Version Model Number3D OCT-1
Company DUNS690542881
Company NameTOPCON CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104560126269102 [Primary]

FDA Product Code

HKICamera, ophthalmic, ac-powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-19
Device Publish Date2025-09-11

On-Brand Devices [3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)]

045621232892513D OCT-1
045711302829573D OCT-1
045601262691023D OCT-1

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