3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton(plu

GUDID 04562123289046

TOPCON CORPORATION

Retinal optical coherence tomography system
Primary Device ID04562123289046
NIH Device Record Keye28bf35f-6dd6-49fd-b3af-c24a8c1995e8
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton(plu
Version Model NumberDRI OCT Triton(plus)
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
GS104562123289046 [Primary]

FDA Product Code

HKICamera, ophthalmic, ac-powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-27
Device Publish Date2018-02-07

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