3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000

GUDID 04562123288261

TOPCON CORPORATION

Retinal optical coherence tomography system
Primary Device ID04562123288261
NIH Device Record Key086e6a4c-5189-4f0d-8840-05b7893c3df5
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
Version Model Number3D OCT-2000
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
GS104562123288261 [Primary]

FDA Product Code

OBOTomography, optical coherence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-19

Devices Manufactured by TOPCON CORPORATION

04571130282773 - REFRACTION SYSTEM Chronos2024-08-09
04571130283350 - AUTO KERATO-REFRACTOMETER KR-8002024-05-17
04571130283374 - AUTO REFRACTOMETER RM-8002024-05-17
04562123288384 - COMPUTERIZED LENSMETER CL-3002023-12-27
04562123288391 - COMPUTERIZED LENSMETER CL-3002023-12-27
04560126268198 - Chinrest CRX-1000 for REFRACTION SYSTEM Chronos2023-11-24
04560126264640 - INFRARED COMMUNICATION UNIT2022-09-08
04560126266071 - KR-1W Viewer2022-09-08

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