3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton

GUDID 04562123289039

TOPCON CORPORATION

Retinal optical coherence tomography system
Primary Device ID04562123289039
NIH Device Record Keyb5856829-237d-4807-9e07-99572206b16b
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton
Version Model NumberDRI OCT Triton
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
GS104562123289039 [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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